MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCESSORY TRACTION; ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Model Number	7210577
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
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.
Additional Manufacturer Narrative
The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed.The rotational collar was separated from the clamp assembly.A functional evaluation was performed.The retaining ring was severed.The rotational collar could not be secured to the clamp assembly.The complaint was confirmed and the root cause has been associated with a fracture problem.Factors, which could have contributed to the complaint event, include an application of unintended excessive force to the device or a weakening of the ring material over time.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.No containment or corrective actions are recommended at this time.

• Brand Name: ACCESSORY TRACTION
• Common Device Name: ACCESSORIES, OPERATING-ROOM, TABLE (KIT)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11840734
• Report Number: 1643264-2021-01876
• Device Sequence Number: 3660928
• Product Code: FWZ
• UDI-Device Identifier: 03596010511256
• UDI-Public: 03596010511256
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7210577
• Device Catalogue Number: 7210577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention