MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE, G3 PLUS GAMMA3®; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-1010
Medical Device Problem Codes	Crack (1135); Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/29/2019
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
Rep reported via voicemail that the distal targeter missed the nail.Fine cracks were observed in the carbon fiber along the neck of the targeter.There was a surgical delay of 15 to 20 minutes.
Event or Problem Description
Rep reported via voicemail that the distal targeter missed the nail.Fine cracks were observed in the carbon fiber along the neck of the targeter.There was a surgical delay of 15 to 20 minutes.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for investigation.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 non-conformity/corrective action history revealed no open issues or actions in place for this product with this failure mode." a review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.Device disposition is unknown.

• Brand Name: TARGET DEVICE, G3 PLUS GAMMA3®
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9611780
• Report Number: 0009610622-2020-00018
• Device Sequence Number: 2642115
• Product Code: LXH
• UDI-Device Identifier: 07613154972173
• UDI-Public: 07613154972173
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 04/08/2020

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 Model Number: 1320-1010
• Device Catalogue Number: 13201010
• Device Lot Number: KME908433
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/29/2019
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1