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

Model Number	1320-0310
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
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
It was reported that during u-lag screw extraction, the tip of the driver broke off.The surgery was completed with the preparation of a substitute.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received u-blade lag screwdriver showed normal signs of usage.However, the pegs at the distal end of the outer sleeve were found to be broken which was due to the application of high torsional force.Closer view of the threaded rod we can see that the flanks threads on the proximal and distal area which might be due to heavy application of force can be due to hammering.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.Based on the investigation, the root cause was attributed to being user-related.The appearance of a breakage surface indicates a brittle fracture caused most likely due to excessive torsional load.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that during u-lag screw extraction, the tip of the driver broke off.The surgery was completed with the preparation of a substitute.

• Brand Name: U-BLADE LAG SCREWDRIVER 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; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14271427
• Report Number: 0009610622-2022-00164
• Device Sequence Number: 12167611
• Product Code: HSB
• UDI-Device Identifier: 04546540377845
• UDI-Public: 04546540377845
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/23/2022

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: 1320-0310
• Device Catalogue Number: 13200310
• Device Lot Number: K136651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female