MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, FULLY THREADED T2 Ø4X50 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18964050S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687); Implant Pain (4561)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported (b)(6) performed surgery for humeral diaphysis fracture.Finished with fixation of 2 proximally screws with oblique and 2 distally screws with ap.(b)(6) patient visited the clinic.Patient was given painkillers for pain.No x-rays were taken.(b)(6) x-rays showed good bone fusion process, but it was found that 2 proximal oblique screws are broken.Revision surgery for explant is scheduled on (b)(6).
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported 1/17 performed surgery for humeral diaphysis fracture.Finished with fixation of 2 proximally screws with oblique and 2 distally screws with ap.2/20 patient visited the clinic.Patient was given painkillers for pain.No x-rays were taken.3/25 x-rays showed good bone fusion process , but it was found that 2 proximal oblique screws are broken.Revision surgery for explant is scheduled on 6/20.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.The reported event could be confirmed since the device was not returned for evaluation and no other evidences were provided.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 to determine the root cause of the complaint event.If any further information is provided or the device is returned, the complaint report will be updated.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 Ø4X50 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19637939
• Report Number: 0009610622-2024-00322
• Device Sequence Number: 20606255
• Product Code: HSB
• UDI-Device Identifier: 04546540202420
• UDI-Public: 04546540202420
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 18964050S
• Device Lot Number: K155B68
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 57 KG