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	07/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the surgery, while milling the bone to remove a screw, the device broke in the surgical zone.There is a missing piece of the device that could not be located in the surgical site.
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.
Additional Manufacturer Narrative
The reported drill breakage was confirmed.The drill fragment was retrieved but not returned for investigation.A visual inspection showed the drill helix had broken off near the shaft, with plastic deformations from contact with a hard object (not bone).The fracture was caused by torsional or bending overload during use.The root cause was attributed to user error, likely due to collision and friction with a screw while attempting removal.No material, manufacturing, or design issues were identified, and no corrective actions are needed.
Event or Problem Description
It was reported that during the surgery, while milling the bone to remove a screw, the device broke in the surgical zone.There is a missing piece of the device that could not be located in the surgical site.

• 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: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 19876346
• Report Number: 0008010177-2024-00076
• Device Sequence Number: 15267530
• Product Code: HBE
• UDI-Device Identifier: 04546540356505
• UDI-Public: 04546540356505
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K070876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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: AL08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 07/31/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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