MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35251380S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2019
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
Customer reported that the gamma nail has broken at lag screw interface.Patient underwent revision surgery.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches with the alleged failure.Visual inspection revealed that the nail was completely broken in the thinned webs of the proximal drill hole for the lag screw.Material abrasion, dents were found in the drill hole most likely caused by a deviating step drill during preparation of the canal for the lag screw.Material abrasion was also found along the periphery of the nail just below the lag screw hole.Material damage had led to unintended damage of the edge in the breakage line resulting in significant material weakening.The appearance of the breakage surfaces revealed the nail had broken in fatigue manner ¿ indicated by the lines of rest, smooth surface topography and missing plastic deformation.The incipient crack had started at the smallest cross section at lateral and had progressed towards medial.A review of the device history for the reported lot did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that ¿in the event the nail is damaged during lag screw reaming, the fatigue strength of the implant may be reduced, which may cause nail to fracture.[¿] never drive the stepdrill with force through the nail, since this may cause severe damage to the nail resulting in the increase risk of the implant failure.¿ based on the investigation, root cause of failure could be attributed to user related issue.Failure was caused due to misaligned step drilling during preparation of the canal for the lag screw, which compromised fatigue strength of the nail.If any further information is provided, the complaint report will be updated.
Event or Problem Description
Customer reported that the gamma nail has broken at lag screw interface.Patient underwent revision surgery.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT 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: 8351623
• Report Number: 0009610622-2019-00074
• Device Sequence Number: 1789088
• Product Code: HSB
• UDI-Device Identifier: 07613252274292
• UDI-Public: 07613252274292
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2019

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 Catalogue Number: 35251380S
• Device Lot Number: K0243B6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 04/22/2019
• 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