MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3130-1200S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	11/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The gamma3 nail broke and was replaced by an artificial hip joint in (b)(6) 2019.
Additional Manufacturer Narrative
The reported event could be confirmed.Device inspection revealed the following: the received nail was found completely broken in the web.The evaluation of the broken surface revealed that the breakage originated from the anterior web.Significant step drill marks are visible around the inside surface of the anterior web as well.Visibility of lines of rest confirmed the breakage to be a fatigue fracture.The posterior web was chipped off rather quickly due to increased tension.Plastic deformation was found around the edge of anterior web due to rubbing of lag screw against it, post-breakage.There were abrupt ridges and other scratch marks which were caused during ex-plantation.Based on the investigation it was observed that the reason for breakage was fatigue stress.This was induced due to the damage done during the drilling for lag screw by a step-drill.Subsequently, the area around the damage, got weakened (reduction in fatigue strength) and over a period of time (10-11 months) the affected web of the nail broke in a fatigue manner.Since the patient is also being revised to an artificial hip joint, there is a possibility of a potential delayed healing, which could have also contributed in the failure, but due to unavailability any post op x-ray, it cannot be ascertained.Thus, based on the investigation the predominantly the failure happened due to a user related issue.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the complaint report will be updated.
Event or Problem Description
The gamma3 nail broke and was replaced by an artificial hip joint in (b)(6) 2019.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM X 130°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9507539
• Report Number: 0009610622-2019-00975
• Device Sequence Number: 11148394
• Product Code: HSB
• UDI-Device Identifier: 04546540375131
• UDI-Public: 04546540375131
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

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 Expiration Date: 08/31/2023
• Device Model Number: 3130-1200S
• Device Catalogue Number: 31301200S
• Device Lot Number: K02D397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Weight: 62