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N/A 7210569SRecalls & reported problems

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

Adverse event reports
6
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010647757), received between Jun 24, 2018 and Aug 25, 2021 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (2 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

  • Positioning Problem2
  • Device Slipped1
  • Explosion1
  • Leak/Splash1
  • Loose or Intermittent Connection1
  • Unintended Movement1

Patient problems

  • No Known Impact Or Consequence To Patient3
  • Bacterial Infection1
  • Cellulitis1
  • Compartment syndrome1
  • Convulsion/Seizure1
  • Decreased Level of Consciousness1
  • Fasciitis1
  • Necrosis1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 25, 2021Unintended Movement; Explosion; Unintended Movement; Explosion

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SPIDER LIMB POSITIONER EXPLODED, CAUSING INJURIES TO THE STAFF. THE INJURIES WERE SUSTAINED WHEN THE SURGEON PRESSED THE FOOT PEDAL AND A VERY LOUD BANG WAS HEARD, THE METAL CYLINDER ON THE BACK OF THE SPIDER SHOT OFF INTO THE SHIN OF THE CRNA. IT CAUSED A LARGE OPEN WOUND THAT APPEARED TO BE ABOUT 4 INCHES IN LENGTH AND ½-1 INCH IN WIDTH. AFTER THE CASE THE SURGEON EXAMINED THE WOUND AND ASKED IF HE WANTED A STITCH OR DURABOND IN THE WOUND. AT THAT POINT THE SURGEON LEFT THE ROOM AND WENT TO HIS NEXT CASE WITHOUT DOING ANYTHING TO THE INJURY. THE CRNA HAD TO BE ADMITTED ON FRIDAY AND TAKEN RIGHT TO THE OR FOR SURGERY. IT WAS MENTIONED THAT THE CRNA HAD COMPARTMENT SYNDROME AND NECROTIZING FASCIITIS. THE MAIN CASE AND PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. THE PATIENT WAS NOT INJURED BUT THE NURSE IS STILL HOSPITALIZED.

    Patient problems: Bacterial Infection; Cellulitis; Compartment syndrome; Convulsion/Seizure; Decreased Level of Consciousness; Fasciitis; Necrosis; Septic Shock; Skin Tears; Swelling/ Edema; Unspecified Respiratory Problem

    MAUDE report 12365295 ↗
  • MalfunctionJul 9, 2020Positioning Problem; Positioning Problem

    IT WAS REPORTED THAT THE SPIDER LIMB WAS NOT WORKING. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A 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 Information

    MAUDE report 10254711 ↗
  • MalfunctionMay 20, 2020Positioning Problem; Positioning Problem

    IT WAS REPORTED THAT THE POSITIONER ARMS DON'T GET FIXED WELL. WHEN PRESSED, THE SPIDER'S ARM FALLS DOWN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 10077381 ↗
  • MalfunctionSep 13, 2018Leak/Splash

    IT WAS REPORTED THAT THE SPIDER HAS LEAKS OF PRESSURE OIL DURING THE SURGERY, THIS CAN CAUSE LOSS OF TRACTION. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7873897 ↗
  • MalfunctionJun 26, 2018Device Slipped

    IT WAS REPORTED THAT THE DEVICE WAS NOT HOLDING TRACTION. NO PATIENT INJURIES WERE REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7637803 ↗
  • MalfunctionJun 24, 2018Loose or Intermittent Connection

    IT WAS REPORTED THAT THE ARM IS NOT LOCKING UP, IT'S SLOW AFTER THE PEDAL IS PRESSED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7632626 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.