MAUDE Adverse Event Report: STRYKER GMBH G4 LONG NAIL RIGHT D10XL360MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	8425-0360S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	05/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "gamma 4 nail implanted 5 months ago.Patient had sub-troch non-union and fell, gamma 4 nail broke.Patient never healed and was allowed to 'wait there' for the surgeon and pa." it was also reported that there was an infection, and the patient was revised.
Additional Manufacturer Narrative
The reported event could be confirmed, since the item was returned in broken condition.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.The device inspection revealed the following: the nail was completely broken in the thinned webs of the proximal drill hole for the lag screw.The appearance of the breakage surfaces identified the nail had broken in fatigue manner ¿ indicated by lines of rest and missing plastic deformation.Provided x-rays were forwarded to a medical expert for review: his comments (in extracts): there was ¿ evidence of poor bone repair capacity due to poor vascularization.¿ if the (lag screw) screw orientates clearly different from the orientation of the femoral neck this might result in additional shear load during the movement of the head when the patient walks.This can result in a non-union.According to received information the patient was not compliant to the surgeon¿s mobilization instructions.The patient experienced sub-troch non-union and fell and the g4 nail broke.Investigation revealed no deficiency of the product.Based on the investigation, the root cause was attributed to a patient related issue.If any information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "gamma 4 nail implanted 5 months ago.Patient had sub-troch non-union and fell, gamma 4 nail broke.Patient never healed and was allowed to 'wait there' for the surgeon and pa." it was also reported that there was an infection, and the patient was revised.

• Brand Name: G4 LONG NAIL RIGHT D10XL360MM 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: 17057006
• Report Number: 0009610622-2023-00190
• Device Sequence Number: 5044581
• Product Code: HSB
• UDI-Device Identifier: 07613327479447
• UDI-Public: 07613327479447
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2023

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 Model Number: 8425-0360S
• Device Catalogue Number: 84250360S
• Device Lot Number: K02A541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2022
• 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: 66 YR
• Patient Sex: Female