MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW,T8 FULL THREAD, 2.7MM/L16MM; SCREW, FIXATION, BONE

Catalog Number	656316S
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that: "after opening a box of 2.7 mm x 16 mm locking screws, ref 656316s, lot 1000604646, during the procedure, the surgical nurse realized that there was another reference in this box: ref 656318s, lot 1000592985 2.7 mm x 18 mm locking screws.".
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Please note correction to d9 (product available to stryker).The reported event could not be confirmed since the affected device was not returned, and no evidence was provided for evaluation.The manufacturing site has investigated this event with the following review: no match can be found for the requested screws lot numbers during manufacturing process.The period between both batches (more than 3 months) is too long for a potential mix-up during manufacturing.Additionally, there were no potential deviations reported during manufacturing regarding both batches.The incoming good inspection information recognized scraped screws during packaging process; however, it is nearly impossible a scrapped screw in march 2025 could be mixed into a batch of screws of june 2025.Furthermore, the packaging stie has also investigated this event with the following review: due to the clear time gap between the two packaging lots, we can reasonably exclude the mix-up occurring at our site.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.No indications of material, manufacturing or design related problems were found during the investigation.More information as well as the affected device must be available to confirm and determine the exact root cause of the issue.If the device is returned or in any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reported that : "after opening a box of 2.7 mm x 16 mm locking screws, ref 656316s lot 1000604646, during the procedure, the surgical nurse realized that there was another reference in this box: ref 656318s lot 1000592985 2.7 mm x 18 mm locking screws.".

• Brand Name: LOCKING SCREW,T8 FULL THREAD, 2.7MM/L16MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23518630
• Report Number: 0008031020-2025-02058
• Device Sequence Number: 9632768
• Product Code: HWC
• UDI-Device Identifier: 07613327070699
• UDI-Public: (01)07613327070699(17)300312(10)1000592985
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: 656316S
• Device Lot Number: 1000592985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2025
• 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