MAUDE Adverse Event Report: STRYKER GMBH HUMERAL NAIL T2 HUMERUS Ø7X250 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18300725S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	11/23/2024
Type of Reportable Event	Serious Injury
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
It was reported, t2 humeral nail broke after primary surgery on (b)(6), intraoperative x rays were taken on (b)(6) with minimal sign of fracture but when patient was monitored on (b)(6) fracture was evident.The implant was removed from the patient and was eliminated.
Additional Manufacturer Narrative
The reported event could be confirmed during analysis of the x-ray images.The nail is broken at the third most distal locking hole.The images were sent to a clinical specialist for review.An implant failure only 1 week after implantation is extremely rare.No medical related error or patient condition related issue could be observed in the images.Without the nail and patient medical records, it is impossible to make any statement about a possible improper procedure (such as severe misdrilling) or a severe patient condition that could explain the premature implant failure.Therefore, due to the lack of more detailed information provided, the root cause of the event could not be determined.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported, t2 humeral nail broke after primary surgery on (b)(6), intraoperative x rays were taken on (b)(6) with minimal sign of fracture but when patient was monitored on (b)(6) fracture was evident.The implant was removed from the patient and was eliminated.

• Brand Name: HUMERAL NAIL T2 HUMERUS Ø7X250 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: 20995679
• Report Number: 0009610622-2024-00966
• Device Sequence Number: 4475850
• Product Code: HSB
• UDI-Device Identifier: 04546540201317
• UDI-Public: (01)04546540201317(17)290531(10)K1BD477
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K032523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: 18300725S
• Device Lot Number: K1BD477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown