MAUDE Adverse Event Report: STRYKER GMBH 4.5MM PERIPHERAL SCREW - 36MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	5572-4536
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "expired device implanted in the patient.We were made aware of expiration before patient was out of the room it was an expired product from january".
Event or Problem Description
As reported: "expired device implanted in the patient.We were made aware of expiration before patient was out of the room it was an expired product from january".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was not returned for evaluation, but the initial surgery was performed in august, and the product label indicates an expiry date of january 2025.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The instructions of use indicate that device should not be used after the expiry date displayed on the label as packaging has not been validated beyond this date.No indications of material, manufacturing or design related problems were found during the investigation.Based on the provided information the product was brought in by the stryker personal but as facility has a strict rule about vendors opening stuff in the or and on the sterile field especially, so implant was handed off the implant to the nurse.The implant was placed and after the surgery she was aware from the sticker that the implant was expired.In general it can be stated that in case of the expiration of shelf-life stryker cannot guarantee the performance and safety for use.The risk of infection will increase with the time passed after the expiry date which is printed on the packaging.Within the labelling there are statements referring to the expiration of shelf life and that the user should ultimately check the expiry date before use: the packaging of all sterile products should be inspected for flaws in the sterile barrier or expiration of shelf life before opening.In the presence of such a flaw or expiration of shelf life, the product must be assumed non-sterile.Based on the investigation root cause can be stated user related as ifu clearly states that all sterile device should be inspected for damage and expiration of shelf life and should not be used after the displayed expiry date.If the device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: 4.5MM PERIPHERAL SCREW - 36MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22922856
• Report Number: 0008031020-2025-01431
• Device Sequence Number: 13350702
• Product Code: KWS
• UDI-Device Identifier: 07613327098761
• UDI-Public: 07613327098761
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K202289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: 01/13/2025
• Device Catalogue Number: 5572-4536
• Device Lot Number: XJ1R5J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2020
• 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