MAUDE Adverse Event Report: STRYKER GMBH G4 TROCH NAIL D10XL170MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81250170S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Limb Fracture (4518)
Date of Event	11/15/2023
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.H3 other text : device disposition is unknown.
Event or Problem Description
As reported: "gamma 4 primary surgery was performed at (b)(6) 2023.The patient fall at (b)(6) 2023 and refracture at the end of the nail was occurred.Revision surgery with gamma3 long nail and u-lag screw was performed at (b)(6) 2023.".
Additional Manufacturer Narrative
The reported refracture could not be confirmed since no evidence was provided [e.G.X-ray images].However, root cause was already given with event description since as per event description ¿the patient fall on (b)(6) 2023 and refracture at the end of the nail was occurred¿.Thus, the reported event is not linked to a deficiency of nail but due to confirmed patient fall, which resulted in a refracture and consequently triggered a revision.This is clear patient related and has to be classified as patient-patient factors issue.With given details no deficiency of the nail in question has been verified.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
As reported: "gamma 4 primary surgery was performed on (b)(6) 2023.The patient fall on (b)(6) 2023 and refracture at the end of the nail was occurred.Revision surgery with gamma3 long nail and u-lag screw was performed on (b)(6) 2023.".

• Brand Name: G4 TROCH NAIL D10XL170MM X 125DEG
• 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: 18326177
• Report Number: 0009610622-2023-00450
• Device Sequence Number: 15266604
• Product Code: HSB
• UDI-Device Identifier: 07613327479058
• UDI-Public: 07613327479058
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2024

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: Lay User/Patient
• Device Catalogue Number: 81250170S
• Device Lot Number: K13B42E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2023
• 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: 80 YR
• Patient Sex: Male