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	09/05/2018
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
During gamma3 surgery, u-blade lag screw connector was broken in two at black marker portion when inserting a u-blade using u-blade inserter.The broken connector was completely removed from the patient.
Event or Problem Description
During gamma3 surgery, u-blade lag screw connector was broken in two at black marker portion when inserting a u-blade using u-blade inserter.The broken connector was completely removed from the patient.
Additional Manufacturer Narrative
The reported event that u-blade lag screw connector gamma3® was alleged of instruments - broken, deformed, worn or scratched could be confirmed.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by improper handling.The device inspection revealed the following: appearance of the breakage surfaces in combination with slightly oblique fracture line indicates that the device broke in a forced brittle manner due to disproportional force and/or bending stresses by levering the instrument.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.

• 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: 7923905
• Report Number: 0009610622-2018-01336
• Device Sequence Number: 1914557
• 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): 11/09/2018

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: K722517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 11/09/2018
• 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