MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3230-0380S
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Patient requested to keep it.
Event or Problem Description
It was reported that g3 nail broke.
Additional Manufacturer Narrative
The reported event of nail breakage was confirmed.According to available information the gamma3 trochanteric nail had broken after an implantation period of approx.2 months.From technical point of view the returned nail broke in fatigue manner after an implantation period of roughly 2 months due to intra-operative damage contributed by (b)(6).From medical point of view contributing factors were identified being unrelieved weight bearing and potentially a statically locked lag screw.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated nail breakage was addressed adequately.There were no actions in place related to the reported event for the subject product.No non-conformity was identified.With available information the event was not linked to a deficiency of the device.
Event or Problem Description
It was reported that g3 nail broke.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM 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: 7446380
• Report Number: 0009610622-2018-00182
• Device Sequence Number: 1125215
• Product Code: HSB
• UDI-Device Identifier: 07613153313045
• UDI-Public: (01)07613153313045
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2018

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: 04/30/2022
• Device Model Number: 3230-0380S
• Device Catalogue Number: 31251200S
• Device Lot Number: K0618BB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 09/03/2018
• Initial Report FDA Received Date: 04/20/2018
• Supplement Report FDA Received Date: 09/17/2018
• 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: 62 YR