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

Catalog Number	7210573
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Event or Problem Description
It was reported that during set up for an arthroscopy, the sterile package of the stabilization shoulder kit was already opened before used.There was a s+n back up device available.There was no delay reported and there was no patient involved.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10 h3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The original packaging was returned and the seal appears to have been continuous around the perimeter of the device.The packaging is very wrinkled and appears to have been crumpled and straightened repeatedly.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the packaging procedure found that the packaging assembler must verify that the pouch is free of pin holes, cuts and seal defects and ensure proper product orientation.The root cause could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the failure include mishandling during shipping or storage.Based on this investigation, the need for corrective action is not indicated.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19417885
• Report Number: 3003604053-2024-00021
• Device Sequence Number: 8747486
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 7210573
• Device Lot Number: 7472LR0400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown