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

Model Number 1320-0310

Device Problem Material Deformation (2976)

Patient Problem Non-union Bone Fracture (2369)

Event Date 12/16/2021

Event Type  Injury  

Manufacturer Narrative

Upon completion of the investigation, additional information will be provided in a supplemental report.

Event 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®
• Type of Device: 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
• MDR Text Key: 283675736
• Report Number: 0009610622-2022-00014
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• 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
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 01/12/2022 Patient Sequence Number: 1