MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, LEFT GAMMA3 Ø11X240MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35251240S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924)
Date of Event	08/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "broken gamma3 nail.Nail explantation on (b)(6) 2024 after nail fracture and implantation of a new nail.The patient experienced a fall on the day of nail breakage.Cause unclear.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was not returned.The reported event could be confirmed, since x-rays of the broken nail were provided.This event was forwarded to medical affairs, with the following review: "on (b)(6), a short gamma nail was implanted for a reverse trochanteric fracture.Biomechanically this is not the implant of choice, there will not be enough three-point fixation for enough stabilization of the fracture and the nail.On (b)(6), the patient experienced a fall, which contributed to the break of the implant.There is a limited amount of callus visible in the fracture area 10 weeks after the initial surgery.The instability in the fracture construct might have already caused wear in the first 10 weeks, which made it weaker and let to the breakage during the fall.Based on the provided information, the root cause of the reported event is multi-factorial: the location of the fracture and the technical aspects of the surgical procedure may have contributed to the event.Furthermore, patient activity levels post-op, co-morbidities may also have contributed to an inadequate load distribution, and therefore the breakage of the implant." based on investigation, the root cause was attributed to a combination of user and patient condition related issue.Firstly, the chosen construct most probably did not enable the stabilization necessary for the healing of the fracture.Secondly, patient factors (such as the reported fall) also contributed to the breakage of the implant.As mentioned by medical affairs, a longer nail providing more stability would have been advised in this case.Nonetheless, the return of the nail would have been necessary for a complete investigation of the event.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "broken gamma3 nail.Nail explantation on (b)(6) 2024 after nail fracture and implantation of a new nail.The patient experienced a fall on the day of nail breakage.Cause unclear.".

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 Ø11X240MM 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: 20226155
• Report Number: 0009610622-2024-00833
• Device Sequence Number: 7240632
• Product Code: HSB
• UDI-Device Identifier: 07613252274223
• UDI-Public: (01)07613252274223(17)280630(10)K158AF9
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K200869
• 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): 11/07/2024

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: 35251240S
• Device Lot Number: K158AF9
• 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: 10/09/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2023
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 74 KG