MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X340MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	32250340S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2018
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
Gamma nail broke.
Event or Problem Description
Gamma nail broke.
Additional Manufacturer Narrative
The reported event that long nail kit r2.0, ti, right gamma3 11x340mm x 125° was alleged of 'implant breakage - nail' could be confirmed.Based on investigation, the root cause was attributed to be patient related.The device inspection revealed the following: the returned nail is indeed completely broken off at the proximal drill hole of the lag screw in fatigue manner after an implantation period of approx.14 weeks.The close up views indicating though that the surface of the breakage is homogenous which again indicate conformity to the given specification.Therefore we can state that the root cause of the nail breakage must have been patient related.Unfortunately no further information could be obtained.Material deformation of the inferior edge of the proximal drill hole at medial referred to typical axial load application.It could not be determined if the patient had been compliant to the weight bearing instructions.This nail breakage was most likely caused by intra-operative material damage contributed by significant axial load application.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 any further information is provided, the investigation report will be updated.

• Brand Name: LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X340MM X 125°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7757231
• Report Number: 0009610622-2018-00587
• Device Sequence Number: 11092588
• Product Code: HSB
• UDI-Device Identifier: 07613153312758
• UDI-Public: 07613153312758
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 32250340S
• Device Lot Number: K0CAB5B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 80