MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL, LEFT GAMMA4 Ø10X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	85250360S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported: "a gamma4 nail implanted about 3 months ago failed at the lag screw site.The nail was completely broken into 2 pieces at this point in the nail.Occurred while the patient was using a stationary bike.Patient had to have a reoperation due to the implant failure.Implant was removed and replaced with a troch nail from a different company.".
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported: "a gamma4 nail implanted about 3 months ago failed at the lag screw site.The nail was completely broken into 2 pieces at this point in the nail.Occurred while the patient was using a stationary bike.Patient had to have a reoperation due to the implant failure.Implant was removed and replaced with a troch nail from a different company.".
Additional Manufacturer Narrative
The reported event could be confirmed since the returned nail was broken.Provided, undated x-rays confirmed the nail breakage.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required currently.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 webs of the proximal drill hole for the lag screw.The appearance of the breakage surfaces identified the nail had broken in a fatigue manner, indicated by lines of rest and missing plastic deformation.The incipient crack had started at the smallest cross section at lateral in the anterior web and progressed towards medial.In this area the edge was damaged by drill marks.This was caused intra-operatively by contact with the step drill while preparing the cannulation for the lag screw.Removed material had weakened the material significantly.In the case presented, a 75-year-old female patient (152lb 5 5 bmi 25,3) had been treated with the above nail on (b)(6) 2023, due to a pathologic subtrochanteric fracture of the left hip.On (b)(6) 2024, the nail was revised due to breakage and replaced with a competitor¿s nail.Four undated x-ray copies were provided for evaluation.Two copies showed the implants in a p-view, post op proximal and distal locking, each.Two copies (1 dub) were demonstrating the broken nail at the proximal; each m-l and a p-view.Pre-op and follow up x-rays were missing.Operation report(s) were not provided.Since no follow up sequences were available for comparison, a medical statement was not justified.Intra-operative material damage had weakened the material significantly.It could not be determined in what way the patient¿s behavior had contributed to the event.With available information a product deficiency was not verified.

• Brand Name: LONG NAIL, LEFT GAMMA4 Ø10X360MM X 125°
• 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: 19068083
• Report Number: 0009610622-2024-00147
• Device Sequence Number: 20033415
• Product Code: HSB
• UDI-Device Identifier: 07613327474619
• UDI-Public: 07613327474619
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 85250360S
• Device Lot Number: K17CAA9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 69 KG