N/A 7210569Recalls & reported problems
Smith & Nephew, Inc. · POSITIONER SPIDER LIMB · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Smith & Nephew Spider Limb positioner is a hydraulic table used to hold a patient's arm or shoulder steady during surgery. The 57 reports mostly describe the arm not holding its position or losing pressure, along with leaking hydraulic fluid and broken seals. One report describes an injury, where the arm collapsed during a shoulder procedure and the surgery was delayed while staff manually supported the shoulder; no deaths were reported. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 57
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 03596010511201), received between Sep 28, 2017 and Aug 18, 2022 — classified as 1 injury, 56 malfunctions.
The most frequently reported specific device problem is “Unstable” (23 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Unstable23
- Leak/Splash9
- Unintended Movement9
- Positioning Problem7
- Positioning Failure5
- Decrease in Pressure4
- Air Leak1
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- No Patient Involvement10
- No Known Impact Or Consequence To Patient9
- No Information2
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 2022Unintended Movement; Unintended Movement
IT WAS REPORTED THAT DURING AN ARM AND SHOULDER PROCEDURE, THE HYDRAULIC SYSTEM OF THE SPIDER LIMB POSITIONER WOULD NOT HOLD THE POSITION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES, USING AN ALTERNATIVE DEVICE AND WITH A CHANGE IN THE SURGICAL TECHNIQUE; THE SHOULDER OF THE PATIENT HAD TO BE MANIPULATED IN THE AIR BY GETTING AN ADDITIONAL STAFF MEMBER. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15254328 ↗MalfunctionJun 29, 2021Unstable; Unstable
IT WAS REPORTED THAT DURING SET UP FOR A SHOULDER SCOPE, THE SPIDER'S ARM WAS NOT FIXING WELL, WHEN PRESSED, THE SPIDER ARM FELL DOWN. IT IS UNKNOWN IF THERE WAS BACKUP DEVICE AVAILABLE, AND NO DELAY OR FURTHER COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12088453 ↗MalfunctionJun 16, 2021Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT, DURING A SHOULDER SCOPE, THE SPIDER WAS LOSING PRESSURE. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO DELAY NOR FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12012374 ↗MalfunctionJun 4, 2021Unstable; Unstable
IT WAS REPORTED THAT, THE SPIDER LIMB POSITIONER WAS BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT WAS NOT HOLDING PRESSURE WHICH MAKES IT A REPORTABLE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11939450 ↗MalfunctionMay 10, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT, DURING SETUP OR INSPECTION, THE SEAL IN THE HYDRAULIC BOTTLES FROM THE SPIDER LIMB POSITIONER BROKE AND OIL STARTED TO LEAK. EVENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11803762 ↗MalfunctionMay 10, 2021Decrease in Pressure; Unstable; Decrease in Pressure; Unstable
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE POSITIONER SPIDER LIMB WAS LOOSING PRESSURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. THE PRESSURE REGAINED ENOUGH TO COMPLETE PROCEDURE WITH THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11796446 ↗MalfunctionMay 6, 2021Unstable; Unstable
IT WAS REPORTED THAT THE POSITIONER SPIDER LIMB WAS NOT WORKING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT FAILED THE WEIGHT TEST WHICH MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11788491 ↗MalfunctionApr 29, 2021Decrease in Pressure; Unstable; Decrease in Pressure; Unstable
IT WAS REPORTED THAT THE POSITIONER SPIDER LIMB WAS NOT HOLDING POSITION AND IT WAS LOOSING PRESSURE. NO CASE REPORTED; THEREFORE, NO PATIENT WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11747095 ↗MalfunctionApr 29, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE POSITIONER SPIDER LIMB WAS LEAKING HYDRAULIC FLUID (OIL). NO CASE REPORTED; THEREFORE, NO PATIENT WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11746906 ↗MalfunctionApr 28, 2021Unstable; Unstable
IT WAS REPORTED THAT BEFORE A SHOULDER PROCEDURE, THE POSITIONER SPIDER LIMB ARMS DID NOT FIX WELL, WHEN PRESSING, THE ARMS FELL DOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. IT IS UNKNOWN IF THERE WAS AN AVAILABLE BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11737255 ↗MalfunctionApr 21, 2021Leak/Splash; Unstable; Unstable
IT WAS REPORTED THAT THE POSITIONER SPIDER LIMB WAS LEAKING OIL AND WOULDN¿T HOLD STEADY ANYMORE. NO CASE REPORTED; THEREFORE, NO PATIENT WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11704285 ↗MalfunctionApr 19, 2021Unstable; Unstable
IT WAS REPORTED THAT, DURING SET UP FOR SURGERY, THE "POSITIONER SPIDER LIMB" COULD NOT LOCK DOWN ON THE OPERATING TABLE, WHEN THE UNIT WAS PUT ON THE BED RAIL, IT COULD NOT BE TIGHTENED AND GOT LOOSE ON THE BED RAIL. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WERE NO PROCEDURAL DELAYS AND NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11690859 ↗MalfunctionApr 15, 2021Unstable; Unstable
IT WAS REPORTED THAT, DURING THE SET-UP OF A SHOULDER PROCEDURE, THE POSITIONER SPIDER LIMB'S ARMS WERE NOT FIXED WHEN PRESSED, THEY FELL. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11672478 ↗MalfunctionApr 12, 2021Unstable; Unstable
IT WAS REPORTED THAT THE POSITIONER SPIDER LIMB WAS SLIPPING/MOVING WHEN UNDER PRESSURE BEFORE A SHOULDER SCOPE. THE PROCEDURE WAS COMPLETED WITH A WORKING SPIDER UNIT. NO INJURIES, DELAY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11653862 ↗MalfunctionApr 5, 2021Unstable; Unstable
IT WAS REPORTED THAT THE POSITIONER SPIDER LIMB WAS NOT HOLDING THE POSITION. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11616658 ↗MalfunctionApr 5, 2021Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE SPIDER LIMB POSITIONER WAS LOSING PRESSURE. NO SIGNIFICANT DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11616501 ↗MalfunctionApr 5, 2021Unstable; Unstable
IT WAS REPORTED THAT DURING SET UP OR INSPECTION FOR A PROCEDURE, THE POSITIONER SPIDER LIMB WOULD NOT LOCK DOWN ON OPERATING TABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INVOLVED AT THE MOMENT OF THE INCIDENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11613101 ↗MalfunctionMar 30, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THERE WAS OIL LEAK FROM BALL JOINT OF SPIDER LIMB POSITIONER AND THAT THE FOOT PEDAL WAS RUSTY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11593298 ↗MalfunctionMar 18, 2021Unstable; Unstable
IT WAS REPORTED THAT DURING THE SET UP INSPECTION, THE POSITIONER SPIDER LIMB WAS NOT HOLDING IN PLACE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11515089 ↗MalfunctionMar 12, 2021Unstable; Unstable
IT WAS REPORTED THAT THE SPIDER II POSITIONER HAS BEEN RETURNED FROM REPAIR, BUT ON CHECKING THE EQUIPMENT IT WAS DISCOVERED THAT THE BATTERY WILL NOT LOAD IN TO THE POSITIONER. TWO DIFFERENT BATTERIES HAVE BEEN TRIED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT FAILED WEIGHT TEST WHICH MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11474124 ↗MalfunctionMar 11, 2021Unstable; Unstable
IT WAS REPORTED THAT THE SECONDARY LEVEL IN THE POSITIONER SPIDER LIMB WAS NOT TIGHTEN. NO CASE REPORTED, THEREFORE THERE WAS NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11466034 ↗MalfunctionFeb 26, 2021Unstable; Unstable
IT WAS REPORTED THAT THE FIXATION OF ARM IS LOOSE IN THE POSITIONER SPIDER LIMB. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11385538 ↗MalfunctionFeb 9, 2021Unstable; Unstable
IT WAS REPORTED THAT THE SPIDER LIMB POSITIONER WAS NOT LOCKING IN POSITION. INCIDENT OCCURRED WHILE SETTING-UP TO THE PROCEDURE. A BACK-UP DEVICE WAS AVAILABLE AND NO DELAYS OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11305361 ↗MalfunctionFeb 3, 2021Leak/Splash; Unintended Movement; Leak/Splash; Unintended Movement
IT WAS REPORTED THAT THE HYDRAULIC CYLINDER WAS LEAKING AND LOOSE. THE ARM OF THE POSITIONER SPIDER MOVES WHEN IN THE LOCKED POSITION. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11271844 ↗MalfunctionJan 28, 2021Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE POSITIONER SPIDER LIMB HANGS THE WEIGHT, IT CANNOT STAY. NO CASE WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11244746 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page