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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the following issue: "event occurred at the hospital.After threading in the rc lag screw driver into the back of the lag screw, already inserted in patient, (this was a removal case) the teeth at the end of the screwdriver broke off and the threaded rod insert was bent.Screw was ultimately able to be removed with same driver due to being cross threaded into the threaded rod portion of the rc lag screw driver.".
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded by the hospital.
Additional Manufacturer Narrative
The reported event could be confirmed, although the device was not returned but an image was shared which confirms the alleged failure.A device inspection was not possible since the affected device was not returned but a picture shared by the customer shows that the pegs at the tip of the driver were broken off.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
The customer reported the following issue: "event occurred at the hospital.After threading in the rc lag screw driver into the back of the lag screw, already inserted in patient, (this was a removal case) the teeth at the end of the screwdriver broke off and the threaded rod insert was bent.Screw was ultimately able to be removed with same driver due to being cross threaded into the threaded rod portion of the rc lag screw driver.".

• 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: nathe hendricks ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12865834
• Report Number: 0009610622-2021-00801
• Device Sequence Number: 1481511
• Product Code: HSB
• UDI-Device Identifier: 04546540377845
• UDI-Public: 04546540377845
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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