MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL, LEFT GAMMA4 Ø10X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	85250380S
Medical Device Problem Codes	Break (1069); Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported: "patient was walking up steps during assigned physical therapy and heard a pop." patient presented with a broken nail which required a revision surgery.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the nail 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 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 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.The incipient crack had started at the smallest cross section at lateral in the anterior web and had 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 77-year-old-female patient (167cm 65kg) had been treated with above nail on (b)(6) 2024.Due to nail breakage the item was revised on (b)(6) 2024.It was reported the patient was walking up steps during assigned physical therapy and heard a pop.The revision surgery was successful.An intertan smith & nephew nail was used for the revision.We received 4 undated x-ray copies showing the nail locked distally with 2 screws in a-p-and m-l-view.Another 2 copies showed the broken nail at proximal, also in 2 views.Further information was not provided.Above medical information was forwarded to medical healthcare practitioner for review.The outcome was: the provided x-ray information did not enlighten the case.Expected callus formation was not identified.A lot of motion could have been possible thus, it could not be identified whether motion or missing bone fusion, or both, had contributed to nail breakage.Based on above investigation, the root cause was attributed to a user related issue.The nail had broken in fatigue mode due to intra-operative material damage.With available information a deficiency of the nail was not verified.
Event or Problem Description
It was reported: "patient was walking up steps during assigned physical therapy and heard a pop." patient presented with a broken nail which required a revision surgery.

• Brand Name: LONG NAIL, LEFT GAMMA4 Ø10X380MM 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: 19139648
• Report Number: 0009610622-2024-00162
• Device Sequence Number: 15798604
• Product Code: HSB
• UDI-Device Identifier: 07613327477627
• UDI-Public: (01)07613327477627(11)220831(17)320731(10)K0AE5FC
• 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: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2024

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: 85250380S
• Device Lot Number: K0AE5FC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 10/06/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White