MAUDE Adverse Event Report: STRYKER GMBH NAIL HOLDING SCREW TIBIA / FEMUR PF T2 ALPHA TIBIA; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23534104
Medical Device Problem Code	Problem with Sterilization (1596)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
It was reported: "the distributor and sales rep should have picked up the necessary instruments from the instrument case before sterilizing the instruments, but forgot to pick up the product in question.It was discovered in the middle of the surgery that the instruments had not been sterilized, and the surgery was interrupted only for the time required for sterilization".
Event or Problem Description
It was reported: "the distributor and sales rep should have picked up the necessary instruments from the instrument case before sterilizing the instruments, but forgot to pick up the product in question.It was discovered in the middle of the surgery that the instruments had not been sterilized, and the surgery was interrupted only for the time required for sterilization".
Additional Manufacturer Narrative
Please note the corrections to h6 results and h6 conclusion codes.The reported event could not be confirmed since the device was not returned for evaluation and not other evidences were provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labelling did not indicate any abnormalities.Indications of material, manufacturing or design related problems were unable tot be identified as the lot number was not communicated.Based on the available information this even is not product related and the issue was caused by improper handling during reprocessing.To avoid such an occurrence in the future, local actions were taken by the distributor.The devices will be placed together in a sterilization case to ensure no instrument has to be removed from the case and all instruments can be sterilized together.If more information is provided, the case will be reassessed.

• Brand Name: NAIL HOLDING SCREW TIBIA / FEMUR PF T2 ALPHA TIBIA
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21340035
• Report Number: 0008031020-2025-00255
• Device Sequence Number: 19795672
• Product Code: HSB
• UDI-Device Identifier: 07613327366280
• UDI-Public: 07613327366280
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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 Catalogue Number: 23534104
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 50 KG