MAUDE Adverse Event Report: STRYKER GMBH FEMORAL NAIL PF, LEFT T2 ALPHA FEMUR ANTEGRADE Ø12X340MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23351234S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "a secondary fracture occurred during nail insertion for a left femoral diaphyseal fracture.Because the guidewire could not be inserted again, the surgeon thought continuing the surgery would affect the patient's condition and decided to close the surgical site.Untreatment of the fracture at left femoral diaphysis and secondary fracture during nail insertion.".
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.
Additional Manufacturer Narrative
Correction: please refer to h6 health impact code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence 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.
Event or Problem Description
As reported: "a secondary fracture occurred during nail insertion for a left femoral diaphyseal fracture.Because the guidewire could not be inserted again, the surgeon thought continuing the surgery would affect the patient's condition and decided to close the surgical site.Untreatment of the fracture at left femoral diaphysis and secondary fracture during nail insertion.".

• Brand Name: FEMORAL NAIL PF, LEFT T2 ALPHA FEMUR ANTEGRADE Ø12X340MM
• 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: 20226050
• Report Number: 0009610622-2024-00834
• Device Sequence Number: 7174896
• Product Code: HSB
• UDI-Device Identifier: 07613327285277
• UDI-Public: (01)07613327285277(17)331231(10)K198ACA
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/03/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 23351234S
• Device Lot Number: K198ACA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2024
• 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 Age: 82 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian