MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG TW DRL/1.6MM 7MM STRYKER; INSTRUMENT

Catalog Number	60-16007
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported that the device broke during surgery.Surgeon located and removed the broken device.A surgical delay of 180 minutes was reported.
Event or Problem Description
It was reported that the device broke during surgery.Surgeon located and removed the broken device.A surgical delay of 180 minutes was reported.
Additional Manufacturer Narrative
Correction: b1 update: h3, h4, h6 the drill breakage event was confirmed, and the broken fragment was retrieved for investigation.Visual inspection revealed that the drill helix was broken near the shaft, and the tip showed damage from impacts and friction with a hard object (not bone).The fracture surface indicated forced rupture due to torsional or bending overload during use.Based on the investigation the root cause of the drill breakage was attributed to a user related issue.Indications for any material, manufacturing or design related problems were not determined in the investigation.Therefore, no corrective and/or preventive actions are deemed to be necessary at this time.

• Brand Name: TW DRL/1.6MM 7MM STRYKER
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: elena drewenskus ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 20141011
• Report Number: 0008010177-2024-00094
• Device Sequence Number: 7462089
• Product Code: HBE
• UDI-Device Identifier: 04546540356505
• UDI-Public: 04546540356505
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K070876
• 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): 02/07/2025

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: 60-16007
• Device Lot Number: 6000097794
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• 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 Sex: Unknown