MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X320MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34250320S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2018
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
On (b)(6) 2018 long gamma nail was implanted in femoris of the right femoral trochanter as primary procedure.About 3 weeks after surgery, the lag screw was backed out, and replaced it to the artificial femoral head at (b)(6) 2018.The bone quality and the skeletal position were not good.
Event or Problem Description
(b)(6) 2018 long gamma nail was implanted in femoris of the right femoral trochanter as primary procedure.About 3 weeks after surgery, the lag screw was backed out, and replaced it to the artificial femoral head at (b)(6) 2018.The bone quality and the skeletal position were not good.
Additional Manufacturer Narrative
The reported event that long nail kit r1.5, ti, right gamma3® ø10x320mm x 125° was alleged of issue (implant revision / removal without implant breakage) could be confirmed.Visual inspection of the received lag screw shows traces of use.There are shiny marks on the periphery of returned lag screw - identified as material abrasion respectively significant bearing points during the period of implantation.The formation of these marks indicates rotation of the lag screw.Nevertheless, no mark or imprint is visible at the ground of the grooves.If the set screw would have been inserted as intended, a small imprint would be visible at the ground of one of the grooves.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.The operative technique gives clear instruction on the entire procedure including implant size selection in the preplanning stage, lag screw length measurement, lag screw insertion and lag screw fixation.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by loosely inserted set screw.If the set screw would have been inserted as intended, a small imprint would be visible at the ground of one of the grooves.If any further information is provided, the complaint report will be updated.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X320MM 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: 8084259
• Report Number: 0009610622-2018-01410
• Device Sequence Number: 1203540
• Product Code: HSB
• UDI-Device Identifier: 04546540374943
• UDI-Public: 04546540374943
• Combination Product (Y/N): N
• PMA/510(K) Number: K032244
• 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): 02/25/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 34250320S
• Device Lot Number: K096E1E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 02/25/2019
• 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: 86 YR