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

Catalog Number	13203010
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2019
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
It was reported that the insertion position indicated by the one shot guide and the position of the actually inserted guide pin were misaligned during gamma3 operation.Therefore, the one shot guide was not used and the operation was continued.Procedure was completed successfully with no adverse consequences or surgical delay reported.
Additional Manufacturer Narrative
Correction: sample not returned.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.The reported device has been in use since 2006, so more than 13 years of service life.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device disposition is unknown.
Event or Problem Description
It was reported that the insertion position indicated by the one shot guide and the position of the actually inserted guide pin were misaligned during gamma3 operation.Therefore, the one shot guide was not used and the operation was continued.Procedure was completed successfully with no adverse consequences or surgical delay reported.

• 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: 9216232
• Report Number: 0009610622-2019-00871
• Device Sequence Number: 13871004
• 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): 12/20/2019

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?: No
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1