MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KIT STABILIZATION SHOULDER (12); ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Model Number	7210573
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an arthroscopy, the elastic band of the shoulder stabilization included within the kit was wearing and tearing easily; it did not allow to adjust it in the patient's extremity.The procedure was completed without delay using a competitor back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The device, which was used in a procedure, was not returned for evaluation.A relationship between the device and the reported incident could not be confirmed.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found other related failures.All risks have been adequately identified in the dfmea/pfmea.A device labeling/ifu review was performed and indicated the instructions for use (ifu) includes recommendations, instructions and precautionary statements for proper use of the product.Factors that are known to contribute to the alleged fault/failure may include a material failure.A supplier correction action has been issued to address this failure.If the product is returned in the future the complaint can be reopened and evaluated.Our quality department will continue to monitor for trends.

• Brand Name: KIT STABILIZATION SHOULDER (12)
• Common Device Name: ACCESSORIES, OPERATING-ROOM, TABLE (KIT)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10321474
• Report Number: 3003604053-2020-00071
• Device Sequence Number: 2951341
• Product Code: FWZ
• UDI-Device Identifier: 03596010511232
• UDI-Public: 03596010511232
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

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: 7210573
• Device Catalogue Number: 7210573
• Device Lot Number: D192391
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 09/01/2020
• 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