MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE LAG SCREW CONNECTOR GAMMA3®; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	13200330
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2018
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
Insert gamma nail and insert u lag screw.Connecting u lag screw connector to the end of the lag screw, inserting the u blade and pushing it in 3 times with the u inserter, the u lag screw connector breaks at the middle groove.Insertion of the u blade gave up and continued with the lag screw inserted, and it ended.
Event or Problem Description
Insert gamma nail and insert u lag screw.Connecting u lag screw connector to the end of the lag screw, inserting the u blade and pushing it in 3 times with the u inserter, the u lag screw connector breaks at the middle groove.Insertion of the u blade gave up and continued with the lag screw inserted, and it ended.
Additional Manufacturer Narrative
The reported event that u-blade lag screw connector gamma3 was alleged of - instruments - broken, deformed, worn or scratched 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.A review of the labeling did not indicate any abnormalities.The file will be closed formally in accordance to our procedures.In case the item and/or substantive information will become available in future the file will be reviewed and reopened.Device was not returned.

• Brand Name: U-BLADE LAG SCREW CONNECTOR 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: 8084096
• Report Number: 0009610622-2018-01409
• Device Sequence Number: 13997794
• Product Code: HSB
• UDI-Device Identifier: 04546540377869
• UDI-Public: 04546540377869
• Combination Product (Y/N): N
• PMA/510(K) Number: K032244
• 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): 12/28/2018

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: 13200330
• Device Lot Number: K00F4BF
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 12/28/2018
• 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
• Patient Age: 84 YR