MAUDE Adverse Event Report: STRYKER GMBH WRIST CARPAL BALL IMPLANT, PLUS, LARGE; PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED

Catalog Number	WABPL
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During inbound processing it was noticed that the item has a hair under the closure seal.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and matches alleged failure.The received packaged device was visually inspected in we can clearly see hair follicle inside the laminated packaging.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.The nature of the complaint doesn¿t necessitate a labelling review since the issue is related to a packaging issue and not due to the design, manufacturing or intended use of the device itself.Based on the available information, the alleged failure was caused due to packaging related issue.In order to address the issue, an nc has been opened to investigate further and prevent its recurrence.If any further information is provided, the investigation report will be reassessed.

• Brand Name: WRIST CARPAL BALL IMPLANT, PLUS, LARGE
• Common Device Name: PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18221407
• Report Number: 0008031020-2023-00412
• Device Sequence Number: 5602390
• Product Code: JWJ
• UDI-Device Identifier: 00886385015460
• UDI-Public: 00886385015460
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K021859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/28/2023

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: Other
• Device Catalogue Number: WABPL
• Device Lot Number: 26366H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2022
• 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