MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ONE SHOT TARGET DEVICE GAMMA3®; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	13203010
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The one shot target device is bent, causing an inaccurate drilling for femoral neck screws.There is a plastic deformation of the device.
Additional Manufacturer Narrative
The reported event that one shot target device gamma3® was alleged of 'instruments - broken, deformed, worn or scratched' could be confirmed.Based on investigation, the root cause was attributed to be user and wear related.Indeed, the reported device has been in use since 2006, so more than 12 years of service life.The bending of the device was probably caused during use, handling or during the numerous reprocessing cycles, in which it is possible that the device was mishandled numerous times.The device inspection revealed the following: the product was returned and it could indeed be confirmed that it is bent.When put on a flat table, the device is not flat on it.The bending of the device results in the loss of it's functionality.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
The one shot target device is bent, causing an inaccurate drilling for femoral neck screws.There is a plastic deformation of the device.

• Brand Name: ONE SHOT TARGET DEVICE GAMMA3®
• 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: 8039731
• Report Number: 0009610622-2018-01377
• Device Sequence Number: 16564847
• Product Code: HSB
• UDI-Device Identifier: 04546540396860
• UDI-Public: 04546540396860
• Combination Product (Y/N): N
• PMA/510(K) Number: K123401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 13203010
• Device Lot Number: KME901191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 02/08/2019
• 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: Other