MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	32250380S
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/13/2018
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.
Event or Problem Description
There was a material breakage of the nail in the hole of the femoral neck screw 10 months after implantation.There was a change to a modular prosthesis.
Additional Manufacturer Narrative
The reported event that long nail kit r2.0, ti, right gamma3® ø11x380mm x 125° was alleged of 'implant breakage - nail' could be confirmed.Based on investigation, the root cause was attributed to be patient related.The failure was caused by delayed union over a 10 months period or an unknown patient incident.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.10 months.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 (as delayed union was indicated).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.From a technical point of view the returned nail broke in fatigue manner after an implantation period of aprox.10 months due to intra-operative damage contributed by high axial load.General aspects: the gamma nail is a temporary implant.Loads on the device produced by load bearing and the patient's activity level will dictate the longevity of the device.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.
Event or Problem Description
There was a material breakage of the nail in the hole of the femoral neck screw 10 months after implantation.There was a change to a modular prosthesis.

• Brand Name: LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X380MM 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: 7982084
• Report Number: 0009610622-2018-01349
• Device Sequence Number: 182638
• Product Code: HSB
• UDI-Device Identifier: 07613153312796
• UDI-Public: 07613153312796
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2019

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: 05/31/2022
• Device Catalogue Number: 32250380S
• Device Lot Number: K093BA0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 01/02/2019
• 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: 78 YR