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

Catalog Number	13200310
Medical Device Problem Codes	Positioning Failure (1158); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The threads of screw driver did not hold the u-lag screw and could not be locked.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: during visual inspection threads of screwdriver found deformed.Threads are pushed back indicating potential hammering from top to engage.Initial threads are rubbed shiny indicating excess contact with the mating part due to application of excess torsional force while tightening.A functional test was done on the returned device using sample lad screw in which it was found that assembly of both components was not possible due to deformation of screwdriver threads.A review of device history for the reported lot did not indicate any abnormalities.No corrective actions are required currently.A review of labelling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during investigation.Based on investigation, the root cause was attributed to be user related issue.The event was caused by application of excess torsional force and external impact when the screwdriver threads were not aligned properly with the mating threads either during the current or previous surgery.If more information will be provided, the case will be reassessed.
Event or Problem Description
The threads of screw driver did not hold the u-lag screw and could not be locked.

• Brand Name: U-BLADE LAG SCREWDRIVER GAMMA3
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• 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: 19803986
• Report Number: 0009610622-2024-00714
• Device Sequence Number: 17988534
• 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: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: 13200310
• Device Lot Number: K0A1573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2021
• 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 Sex: Male