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

Model Number	1320-0310
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "a patient who had undergone surgery about a year and a half ago was re-operated on after a postoperative pseudoarthrosis was identified.For reasons unknown, a long gamma nail and u-lag screw were used, but the u-blade was not installed on the u-lag screw.During revision surgery, when removing the u-lag screw, the u-lag screw driver did not turn easily and the tip were deformed.The surgeon prepared a substitute and started to remove it again, but the tip of the second screwdriver were also deformed.Eventually, it was able to be removed, but it extended the surgery time by more than 5 hours.".
Additional Manufacturer Narrative
The reported event was confirmed.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.Generally, 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 damaged and bent.The nature of found damages indicate excessive rotational force and/or levering the screwdriver during use.It was reported that the u-lag set was initially implanted without the required u-blade.The labelling clearly indicates the use of the u-blade.It was also reported that the surgeon was required to scrape away bony ingrowth in the screw with wires, etc.Which caused delay in surgery.A product deficiency was not verified.Origin of the complaint is the initial omission of a required implant.
Event or Problem Description
As reported: "a patient who had undergone surgery about a year and a half ago was re-operated on after a postoperative pseudoarthrosis was identified.For reasons unknown, a long gamma nail and u-lag screw were used, but the u-blade was not installed on the u-lag screw.During revision surgery, when removing the u-lag screw, the u-lag screw driver did not turn easily and the tip were deformed.The surgeon prepared a substitute and started to remove it again, but the tip of the second screwdriver were also deformed.Eventually, it was able to be removed, but it extended the surgery time by more than 5 hours.".

• 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: 13236656
• Report Number: 0009610622-2022-00014
• Device Sequence Number: 19934733
• Product Code: HSB
• UDI-Device Identifier: 04546540377845
• UDI-Public: 04546540377845
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1320-0310
• Device Catalogue Number: 13200310
• Device Lot Number: K131826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2012
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 85 KG