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

Model Number	7210573
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the arcr procedure, the bandage could not be peeled off firmly and was broken when it was stretched.No delay and a back up from a competitor was used to complete the procedure.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3, h6: the device, which was used in a procedure, was returned for evaluation.There was a relationship between the reported event and the device.A visual inspection was performed and showed the coban material was deteriorated.The process used during the manufacturing timeframe created a reduced coating weight on the coban.A supplier preventative action has been issued to address this failure.A review of the manufacturing records found that the product didn¿t meet specifications at the time of manufacture.A complaint history review found other related failures.The risk management files contain the reported failure mode.No update required.Instructions for use contains recommendations and precautionary statements for proper use of product.Further investigation into the reported failure will be conducted to determine if additional actions are required.

• 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: 10639103
• Report Number: 3003604053-2020-00119
• Device Sequence Number: 19484204
• Product Code: FWZ
• UDI-Device Identifier: 03596010511232
• UDI-Public: 03596010511232
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/30/2020

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 Expiration Date: 08/01/2022
• Device Model Number: 7210573
• Device Catalogue Number: 7210573
• Device Lot Number: D192391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 10/30/2020
• 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: Other; Required Intervention