MAUDE Adverse Event Report: STRYKER GMBH STEPDRILL FOR LAG SCREW T2; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18063025
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the surgeon was drilling to position the second cervical screw of a reconstruction nail when the drill bit broke, leaving the end of the device in the femoral neck.Increased anesthesia time, while a solution was found to remove the broken end.Removal of device." the procedure was delayed by between 30 and 45 minutes.The alignment of the drill in the nail hole was checked before the nail was placed.Freehand extraction: the broken bit followed the guide pin when the operator removed it by hand.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Corrections: please refer to sections d4 (lot code) and d9.The affected device was not returned.Nonetheless, an intra-operative photo of it was received and could confirmed the reported event.It can be seen that the drill's tip is broken, a fragment was detached.The lot # is not visible on the photo.Note: the wrong instrument (lot # 18063026, catalog # ku66255) was returned.It has been confirmed by the user that the reported event concerns a drill catalog # 18063025.Despite multiple attempts, the correct device has not been returned.Despite confirmation of the drill breakage, it was not possible to determine the root cause.The return of the instrument would have been necessary for a detailed investigation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the surgeon was drilling to position the second cervical screw of a reconstruction nail when the drill bit broke, leaving the end of the device in the femoral neck.Increased anesthesia time, while a solution was found to remove the broken end.Removal of device." the procedure was delayed by between 30 and 45 minutes.The alignment of the drill in the nail hole was checked before the nail was placed.Freehand extraction: the broken bit followed the guide pin when the operator removed it by hand.

• Brand Name: STEPDRILL FOR LAG SCREW T2
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21100495
• Report Number: 0009610622-2025-00005
• Device Sequence Number: 15658055
• Product Code: LXH
• UDI-Device Identifier: 04546540414588
• UDI-Public: 04546540414588
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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 Catalogue Number: 18063025
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown