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NA 72203299SRecalls & reported problems

Smith & Nephew, Inc. · SPIDER2 LIMB POSITIONER SERVICE REPLACEMENT · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Smith & Nephew Spider 2 limb positioner holds a patient's arm or leg in place during surgery. Reports mostly describe the unit losing power or failing to hold position so the limb drops, plus overheating with a burning smell, oil leaks and jamming. There are 25 adverse event reports naming its identifier, with no deaths and no injuries. No recalls name 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
25
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00885554029673), received between Oct 9, 2017 and Jun 1, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 1 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Overheating of Device6
  • Unintended Movement5
  • Leak/Splash4
  • Physical Resistance/Sticking3
  • Unstable3
  • Detachment Of Device Component1
  • Device Operates Differently Than Expected1
  • Device Slipped1

Patient problems

  • No Clinical Signs, Symptoms or Conditions15
  • No Known Impact Or Consequence To Patient10

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 1, 2026Unintended Movement; Unexpected Shutdown

    IT WAS REPORTED THAT DURING A REVERSE SHOULDER PROCEDURE, THE SPIDER 2 TENET LOST POWER AND THE ARM DROPPED TO THE FLOOR WHILE THE PATIENT WAS ATTACHED. WITH MULTIPLE ATTEMPTS, POWER WAS NOT ABLE TO BE RESTORED. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER NO DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25354275 ↗
  • MalfunctionFeb 2, 2026Leak/Splash; Unintended Movement

    IT WAS REPORTED THAT, DURING A PROCEDURE, A SPIDER 2 WAS CONSISTENTLY NOT HOLDING POSITION. THE PATIENT'S ARM DROPPED AND THE SURGEON HAD TO CATCH IT. CHARGER, BATTERIES AND OUTLETS WERE SWITCHED BUT IT DID NOT WORK. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24233980 ↗
  • MalfunctionOct 7, 2025Leak/Splash; Mechanical Jam; Unintended Movement; Leak/Splash; Mechanical Jam; Unintended Movement

    IT WAS REPORTED THAT, DURING SURGERY, IT WAS NOTICED THAT A SPIDER 2 WORKED FOR FIVE MINUTES AND LICKED UP, AND DID NOT MOVE ANYMORE. THE PROCEDURE WAS RESUMED, AFTER A 45-MINUTE DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23235376 ↗
  • MalfunctionFeb 14, 2024Overheating of Device; Overheating of Device

    IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE SPIDER 2 TENET WAS OVERHEATING WHEN IT WAS MOVED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18704372 ↗
  • MalfunctionJan 24, 2024Overheating of Device; Physical Resistance/Sticking; Overheating of Device; Physical Resistance/Sticking

    IT WAS REPORTED THAT THE SPIDER 2 TENET WAS STUCK, WAS GETTING HOT, AND WAS SMELLING LIKE BURN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18571282 ↗
  • MalfunctionDec 12, 2023Leak/Splash; Unstable; Insufficient Device Problem Information; Leak/Splash; Unstable; Insufficient Device Problem Information

    IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE SPIDER WAS LEAKING OIL OUT THE JOINT AND STOPPED WORKING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18313629 ↗
  • MalfunctionSep 26, 2023Overheating of Device; Overheating of Device

    IT WAS REPORTED THAT DURING SET UP, THE SPIDER 2 TENET WAS OVERHEATING. A BACK UP DEVICE WAS AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17821430 ↗
  • MalfunctionSep 4, 2023Electrical Shorting; Electrical Shorting

    IT WAS REPORTED THAT DURING SET UP, SOMETHING WAS BURNING ON THE SPIDER LIMB POSITIONER. THERE WAS A BACK-UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. NO PATIENT INVOLVEMENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17676668 ↗
  • MalfunctionMay 18, 2023Overheating of Device; Overheating of Device

    IT WAS REPORTED THAT THE SPIDER POSITIONER WAS OVERHEATING WHEN IT WAS USED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16954934 ↗
  • MalfunctionSep 24, 2022Overheating of Device; Overheating of Device

    IT WAS REPORTED THAT DURING SET UP, THE SPIDER 2 TENET WAS OVERHEATING. A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15476254 ↗
  • MalfunctionJun 29, 2022Unintended Movement; Unintended Movement

    IT WAS REPORTED THAT DURING A SHOULDER SCOPE, THE TENET SPIDER'S ARM WAS NOT HOLDING. UPON CONNECTING THE PATIENTS ARM TO THE DEVICE, THE HYDRAULIC FAILED. THE PATIENT'S ARM WAS NOT INJURED. THE DEVICE WAS RE-DRAPED IN A STERILE FASHION, BUT THE ARM FAILED AGAIN IN THE SAME MANNER. THE PROCEDURE WAS COMPLETED WITHOUT A DELAY, BY WRAPPING STERILE COBAN AROUND THE LOCKING MECHANISM, AND STERILE PERSONNEL SUPPORTING THE SPIDER ARM THROUGH THE DURATION OF THE PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14860614 ↗
  • MalfunctionJun 27, 2022Unintended Movement; Unintended Movement

    IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY, THE TENET SPIDER'S ARM WAS NOT HOLDING. THE PATIENT'S LEG WAS SUPPORTED WITH A SUSPENSION DEVICE AND THE SPIDER WAS USED FOR TRACTION TO GAIN ACCESS TO THE ANKLE JOINT. WHEN THE PEDAL WAS ENGAGED TO MOVE THE SPIDER ARM FOR TRACTION, THE ARM DISCONNECTED FROM THE PATIENT DEVICE AND FELL TO THE FLOOR. THE PROCEDURE WAS COMPLETED WITHOUT A DELAY, BY WRAPPING STERILE COBAN AROUND THE LOCKING MECHANISM, AND STERILE PERSONNEL SUPPORTING THE SPIDER ARM THROUGH THE DURATION OF THE PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14836639 ↗
  • MalfunctionJun 2, 2022Unstable; Unstable

    IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, WHILE USING THE SPIDER 2 SWITCH DRAPE CONNECTION PORT, THE ARM RELEASED AND DROPPED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED; HOWEVER NO SURGICAL DELAY WAS REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14573436 ↗
  • MalfunctionMar 23, 2021Leak/Splash; Physical Resistance/Sticking; Leak/Splash; Physical Resistance/Sticking

    IT WAS REPORTED THAT THE SPIDER 2 WAS HAVING VACUUM PROBLEMS IN THE PEDAL AREA. THE DEVICE'S ARM MOVES WITH DIFFICULTY AND THERE IS A LEAK NOISE IN THE PEDAL. 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 11555510 ↗
  • MalfunctionFeb 8, 2021Unstable; Unstable

    IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE SVCE REPL, SPIDER 2, TENET 7615 DID NOT HOLD THE POSITION. THE PROCEDURE WAS COMPLETED WITH A DELAY OF 30 MINUTES OR LESS USING 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 11299041 ↗
  • MalfunctionJun 7, 2020Positioning Failure; Positioning Failure

    IT WAS REPORTED THAT THE TOP JOINT OF THE SPIDER TENET WAS JAMMED AND WON'T ARTICULATE. INCIDENT OCCURRED BEFORE A SHOULDER ARTHROSCOPY. A BACK-UP DEVICE WAS AVAILABLE AND IT IS UNKNOWN IF THERE WAS ANY DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10126695 ↗
  • MalfunctionAug 18, 2018Physical Resistance/Sticking

    IT WAS REPORTED THAT IT WAS FOUND THE BALL JOINT CLOSEST TO THE SPIDER IS STICKING EVEN WHEN UNLOCKED. WHEN TESTED IT CAN BE FORCED LOOSE WITHOUT TOO MUCH EFFORT BUT MORE THAN THE PROVIDERS WOULD LIKE. IT HAS PROBLEMS TO BE POSITIONED PROPERLY. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7795928 ↗
  • MalfunctionJul 10, 2018Noise, Audible

    IT WAS REPORTED THAT THE DEVICE WAS MAKING WEIRD NOISES. NO PATIENT INJURY WAS REPORTED. NO BACK-UP DEVICE AVAILABLE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7676079 ↗
  • MalfunctionJun 21, 2018Overheating of Device

    IT WAS REPORTED THAT THE DEVICE WAS GETTING HOT. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7627336 ↗
  • MalfunctionFeb 12, 2018Device Operates Differently Than Expected

    IT WAS REPORTED THAT THE DEVICE WAS NOT MOVING PROPERLY. THERE WAS NO BACKUP AVAILABLE. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7265385 ↗
  • MalfunctionJan 8, 2018Device Slipped

    THE HINGE JOINT IS SLIPPING. NO PATIENT INJURY OR SIGNIFICANT TIME DELAY REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7173802 ↗
  • MalfunctionJan 5, 2018Detachment Of Device Component

    IT WAS REPORTED THAT THE HEEL PAD HAS DETACHED FROM THE BOOT. THE GLUE HAS FAILED. THE DOCTOR ASKED FOR MORE TRACTION AND WASN¿T ABLE TO APPLY IT BECAUSE OF EXCESSIVE HEEL LIFT-OFF. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO PATIENT INJURIES WERE REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7167243 ↗
  • MalfunctionNov 13, 2017Power Conditioning Problem

    IT WAS REPORTED THAT THE SPIDER 2 TENET WASN'T WORKING DUE TO POWER ISSUES. PROCEDURE WAS COMPLETED USING ANOTHER TYPE OF DEVICE. NO PATIENT INJURY REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7026207 ↗
  • MalfunctionNov 7, 2017Loss of Power

    IT WAS REPORTED THAT THE SPIDER 2 TENET STOPPED WORKING; 2 BATTERIES WERE REPLACED BUT IT WOULD STILL NOT WORK. NO PATIENT INJURY REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7006644 ↗
  • MalfunctionOct 9, 2017Material Too Rigid or Stiff

    IT WAS REPORTED THAT IN A SPIDER TENET THE UPPER MOST ARM IS VERY STIFF. NO PATIENT INJURY REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6933284 ↗

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