MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, FULLY THREADED T2 Ø5X55 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965055S
Medical Device Problem Codes	Positioning Failure (1158); Material Fragmentation (1261)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	10/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported that the screw was not screwed into the nail.When removing it, a metal chip was formed.No screw was inserted.10/22/2024: additional information received: the procedure was completed without replacing a screw in the place where it was supposed to be placed.No consequences for the patient.
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was not returned.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.Known from former cases it could not be excluded that it occurred due to initially slight oblique positioning of locking screw during insertion step rim contact at screw hole which resulted in shared off material.However, due to missing device a physical evaluation is impossible and based on details given a further technical statement could not be made.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.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
The customer reported that the screw was not screwed into the nail.When removing it, a metal chip was formed.No screw was inserted.10/22/2024 - additional information received: the procedure was completed without replacing a screw in the place where it was supposed to be placed.No consequences for the patient.
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was finally received.Sections h6 (method, results and conclusion codes) and h11 were updated accordingly.The reported event could be confirmed since the device returned revealed an obviously damaged thread.Known from former cases it could not be excluded that it occurred due to initially slight oblique positioning of locking screw during insertion step (rim contact at screw hole) which also resulted in shared off material during the step of screw removal during unturning the screw, which is confirmed by clear signs of damage verified during physical evaluation of item in question.Based on above the case is rather linked to an inadequate handling during procedure and has to be classified as user-customer-application errors; person makes a mistake, slip.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
The customer reported that the screw was not screwed into the nail.When removing it, a metal chip was formed.No screw was inserted.10/22/2024 - additional information received: the procedure was completed without replacing a screw in the place where it was supposed to be placed.No consequences for the patient.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 Ø5X55 MM
• 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: 20625805
• Report Number: 0009610622-2024-00902
• Device Sequence Number: 21030810
• Product Code: HSB
• UDI-Device Identifier: 04546540202529
• UDI-Public: (01)04546540202529(17)290331(10)K1B27D4
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2025

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 Catalogue Number: 18965055S
• Device Lot Number: K1B27D4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 11/29/2024; 06/23/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 12/20/2024; 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• 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