MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3® Ø10.5X90MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	30660090S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that, when using the u lag screw, the u blade was inserted manually into the flute of the u lag screw, the u blade could not be inserted to the optimum position.The set screw was loosened, the u lag screw was reversely rotated (pulled back), and the u blade was protruded from the outer cortical bone again to try inserting the u blade manually, but this could not be solved.Unable to use u lag screw, changed to gamma 3 lag screw.No adverse consequences or surgical delay were reported.
Event or Problem Description
It was reported that, when using the u lag screw, the u blade was inserted manually into the flute of the u lag screw, the u blade could not be inserted to the optimum position.The set screw was loosened, the u lag screw was reversely rotated (pulled back), and the u blade was protruded from the outer cortical bone again to try inserting the u blade manually, but this could not be solved.Unable to use u lag screw, changed to gamma 3 lag screw.No adverse consequences or surgical delay were reported.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the functional inspection revealed that devices are working as intended.Based on investigation, the root cause was attributed to a user related issue.U-clip insertion requires greater force and cannot be done by hand.The failure could have been caused due to insufficient force to insert the u-clip at its final position into the lag screw flutes.Visual inspection of the received u-blade set, ti gamma3 shows traces of use.Thread profiles were not damaged at the edges of the both flutes, along which u-clip glides.No further damage was found.Functional inspection revealed that, u-clip was able to be inserted along the flutes of the lag screw to its final position.U-blade set is working as intended.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 material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The operative technique guide states: ¿the gamma3 rc u-clip inserter is required to move the gamma3 rc u-clip into its final position.The gamma3 rc u-clip will now start to spread to the anterior and posterior side.This procedure requires greater force and cannot be done by hand.¿ if any further information is provided, the complaint report will be updated.

• Brand Name: U-BLADE SET, TI GAMMA3® Ø10.5X90MM
• 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: 8483034
• Report Number: 0009610622-2019-00140
• Device Sequence Number: 11017815
• Product Code: HSB
• UDI-Device Identifier: 04546540595980
• UDI-Public: 04546540595980
• Combination Product (Y/N): N
• PMA/510(K) Number: K043431
• 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): 06/14/2019

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 Expiration Date: 12/31/2022
• Device Catalogue Number: 30660090S
• Device Lot Number: K022BC2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1