MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE T2 GTN; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18061600
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that the nail targeting device disassociated at the neck.The nail was unusable without targeting device, there was a surgical delay of 7 minutes, and an alternate type of nail was used as a result.No death or serious injury was reported.
Event or Problem Description
It was reported that the nail targeting device disassociated at the neck.The nail was unusable without targeting device, there was a surgical delay of 7 minutes, and an alternate type of nail was used as a result.No adverse consequences to the patient were reported.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches with the alleged failure mode.Visual inspection of the received target device t2 gtn shows traces of use.Steel part of target device which holds the nail was completely separated apart from the fiber body.During manufacturing, both parts were assembled with press fitted fiber rivets along with glue.They were completely broken off.No further visual damage was observed.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.However, based on the visual inspection, possible causes of the failure could be over-bending of target device, hitting the target arm with excessive force without using strike plate, which has to be attributed to user related issue.This is the first reported case with this lot number.A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.

• Brand Name: TARGET DEVICE T2 GTN
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8448167
• Report Number: 0009610622-2019-00124
• Device Sequence Number: 11484978
• Product Code: LXH
• UDI-Device Identifier: 04546540682239
• UDI-Public: 04546540682239
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2019

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: 18061600
• Device Lot Number: KME 909177 242567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1