MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW IMN SCREWS Ø5X35MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23605035S
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
Sales reported the following:" we just inserted an gamma3 long nail, and the 5.0 locking screw (2360-5035s) is completely stuck in the distal section.It was slightly misaligned, but there's no movement possible in the screw, neither forward nor backwards, and we've tried all available options.The decision has been made to leave it in place.".
Event or Problem Description
Sales reported the following:" we just inserted an gamma3 long nail, and the 5.0 locking screw (2360-5035s) is completely stuck in the distal section.It was slightly misaligned, but there's no movement possible in the screw, neither forward nor backwards, and we've tried all available options.The decision has been made to leave it in place.".
Additional Manufacturer Narrative
The device was not returned for investigation.However, images of the construct were provided.It can be seen that one of the screw is not fully inserted through the hole and into the bone, as mentioned by the reporter.Therefore, it is very likely the screw is in fact jammed in the nail as reported: the event could be confirmed.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 detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LOCKING SCREW IMN SCREWS Ø5X35MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20495407
• Report Number: 0009610622-2024-00877
• Device Sequence Number: 11666453
• Product Code: HSB
• UDI-Device Identifier: 07613327366198
• UDI-Public: 07613327366198
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K191271
• 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): 12/20/2024

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 Catalogue Number: 23605035S
• Device Lot Number: UNKNOWN
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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