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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "nail breaks when placed in the nail insertion space".Additional information received 10/17/24; it was a primary surgery.Surgeon drilled the canal, put a humerus nail, and when adjusting the compression screw, he leaned 2.7 screwdriver on the proximal part of the nail and the nail material became deformed.Nail had to be removed and another one with same measures was replaced.There was no debris, only material fatigue.
Event or Problem Description
As reported: "nail breaks when placed in the nail insertion space".Additional information received (b)(6) 2024; it was a primary surgery.Surgeon drilled the canal, put a humerus nail, and when adjusting the compression screw, he leaned 2.7 screwdriver on the proximal part of the nail and the nail material became deformed.Nail had to be removed and another one with same measures was replaced.There was no debris, only material fatigue.
Additional Manufacturer Narrative
Correction - please refer to d9 - the device was not returned.The reported event could not 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 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: 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: 20571068
• Report Number: 0009610622-2024-00899
• Device Sequence Number: 8095259
• Product Code: HSB
• UDI-Device Identifier: 04546540201317
• UDI-Public: (01)04546540201317(17)281130(10)K18F448
• 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): 01/16/2025

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: 18300725S
• Device Lot Number: K18F448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 12/24/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2023
• 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
• Patient Sex: Unknown