MAUDE Adverse Event Report: STRYKER GMBH LAG SCREW DRILL FOR 1.7MM SCREWS, DIAM.1.3/1.7X73MM, STRYKER SHAFT END, 1/P; BIT, DRILL

Catalog Number	60-88117
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "an electric motor test was performed.The drill was handed to the surgeon to begin bone drilling, during which the drill bit broke, leaving a fragment inside.The specialist did not remove it due to the difficulty of extraction.The osteosynthesis procedure continued using a new drill bit.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the affected device was not returned and no other evidence was shared for evaluation.A device inspection was not possible since the affected device was not returned.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.More information as well as the affected device must be available in order to determine the exact root cause of the issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "an electric motor test was performed.The drill was handed to the surgeon to begin bone drilling, during which the drill bit broke, leaving a fragment inside.The specialist did not remove it due to the difficulty of extraction.The osteosynthesis procedure continued using a new drill bit.".

• Brand Name: LAG SCREW DRILL FOR 1.7MM SCREWS, DIAM.1.3/1.7X73MM, STRYKER SHAFT END, 1/P
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23053302
• Report Number: 0008031020-2025-01529
• Device Sequence Number: 8685905
• Product Code: HTW
• UDI-Device Identifier: 07613153159940
• UDI-Public: 07613153159940
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: 60-88117
• Device Lot Number: 885401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Sex: Male