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

Catalog Number	13200310
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "when screwing in the femoral neck screw, the spikes broke off at the tip.Both spikes broke off when turned in.It was not driven in with a hammer.One spike was found, the other was not.A second tray had to be opened (another patient was delayed as a result).This extended the surgery time by about 30 min.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "when screwing in the femoral neck screw, the spikes broke off at the tip.Both spikes broke off when turned in.It was not driven in with a hammer.One spike was found, the other was not.A second tray had to be opened (another patient was delayed as a result).This extended the surgery time by about 30 min.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and matches the alleged failure.The received u-blade lag screwdriver had both his pegs broken off with the material deformation in the counterclockwise direction.This indicates that the breakage happened during the tightening process.Fragments were not received for the analysis.We can see clear deformation in the connecting threads of the lag screw.The breakage happened during the application of excessive force while tightening.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.Based on investigation, the root cause was attributed to be user related.If any additional information is provided, the investigation will be reassessed.

• 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: 17758812
• Report Number: 0009610622-2023-00319
• Device Sequence Number: 15246980
• Product Code: HSB
• UDI-Device Identifier: 04546540377845
• UDI-Public: 04546540377845
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2023

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: K0B161F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• 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: Unknown