NA 7210577Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 03596010511256), received between Jun 26, 2018 and Jun 21, 2021 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Unstable” (7 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

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2021Unstable; Unstable

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY, OUTSIDE THE PATIENT, THE ACCESSORY TRACTION DOES NOT LOCK IN ROTATION. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. SURGICAL DELAY LESS THAN OR EQUAL TO 30 MINUTES. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12036280 ↗
• MalfunctionJun 18, 2021Unstable; Unstable

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY PROCEDURE, THE TRACTION ACCESSORY WAS NOT LOCKING IN ROTATION. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. NO SIGNIFICANT DELAY AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12029200 ↗
• MalfunctionJun 17, 2021Unstable; Unstable

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, USING A LATERAL POSITION WITH SPIDER TENET 2 THE ACCESSORY TRACTION DID NOT LOCK IN ROTATION. PROCEDURE FINISHED WITH SAME DEVICE. SURGICAL DELAY OF LESS THAN OR EQUAL TO 30 MINUTES. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12015882 ↗
• MalfunctionJun 14, 2021Unstable; Unstable

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, THE ACCESSORY TRACTION DEVICE DOESN¿T LOCK IN ROTATION. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. NO SIGNIFICANT DELAY AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11996521 ↗
• InjuryMay 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, AFTER SETTING THE SPIDER, THE TRACTION ACCESSORY WAS SEPARATED WHEN TURNING IT. THE PROCEDURE WAS COMPLETED USING THE S+N LATERAL TRACTION POSITIONER. A SIGNIFICANT DELAY WAS REPORTED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11840734 ↗
• MalfunctionApr 25, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE ACCESSORY TRACTION ARM WAS NOT FIXED PROPERLY AND IT HAD A QUICK CONNECTOR FAILURE. 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 11721850 ↗
• MalfunctionMar 9, 2021Unstable; Unstable

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE LOCK OF THE "ACCESSORY TRACTION" WAS MALFUNCTIONING, IT WAS SLIPPING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. 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 11448954 ↗
• MalfunctionJan 7, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING SURGERY, THE CLAMP OF THE TRACTION ACCESSORY DID NOT HOLD. NO SIGNIFICANT DELAY OR OTHER COMPLICATIONS WERE REPORTED. IT IS UNKNOWN IF THERE WAS A BACKUP AVAILABLE. 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 11131691 ↗
• MalfunctionNov 26, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE DEVICE 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 10911958 ↗
• MalfunctionOct 29, 2020Unstable; Material Deformation; Positioning Problem; Unstable; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT, THE RELEASE BUTTON OF THE "ACCESSORY TRACTION" WAS NOT WORKING, IT LOOKED BENT AND DAMAGED, THE CLAMP WAS NOT HOLDING THE BAR ANYMORE. 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; No Patient Involvement

  MAUDE report 10759971 ↗
• MalfunctionOct 15, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE ACCESSORY TRACTION DEVICE WAS NOT HOLDING. 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 Patient Involvement

  MAUDE report 10687136 ↗
• MalfunctionAug 27, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE ACCESSORY, TRACTION WONT ROTATE; 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 Patient Involvement

  MAUDE report 10463189 ↗
• MalfunctionAug 19, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE ACCESSORY TRACTION HAD A MANUFACTURER DEFECT IN THE BLACK LOCKING HANDLE. IT COULD NOT LOCK THE ROTATION OF THE TRACTION PIECE. 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 Patient Involvement

  MAUDE report 10426450 ↗
• MalfunctionAug 7, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE BLACK LEVER OF THE ACCESSORY TRACTION WAS LOOSE AND IT WAS NOT STAYING TIGHT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10378654 ↗
• MalfunctionJun 1, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE ACCESSORY TRACTION WAS NOT LOCKING. THE EVENT HAPPENED AFTER SURGERY. 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 10107511 ↗
• MalfunctionMar 19, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY, THE SYSTEM HOLDER IS NOT GETTING LOCKED. IT IS LOOSE AND CANNOT HANDLE THE SHOULDER. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED HOWEVER NO SIGNIFICANT 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 Known Impact Or Consequence To Patient

  MAUDE report 9857561 ↗
• MalfunctionDec 23, 2019Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE TENET ACCESSORY TRACTION BAR IS BENT AND THE LOCKING MECHANISM IS COMPROMISED. THIS ATTACHMENT WOULD NOT LOCK THE HAND HOLDING ATTACHMENT INTO PLACE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A 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 Known Impact Or Consequence To Patient

  MAUDE report 9513474 ↗
• MalfunctionJun 26, 2018Device Slipped

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7637797 ↗