MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG 1.5X110MM DRILL, 20MM WL, COLOR DEPTH MARKS; INSTRUMENT

Model Number	60-15620
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
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 drill broke off into the patient mandible intra-operatively.The broken piece was removed, and the surgery was completed successfully.
Additional Manufacturer Narrative
The reported event that the drill broke off could be confirmed.The visual inspection revealed that drill helix has been broken off near the shaft at the working area.The broken off fragment could be retrieved and was returned for investigation.Within the investigation it was determined that the fracture surface shows the appearance of a forced rupture resulting from torsional overload during application.Furthermore, the cutting edge shows the collision area where the drill collided against a hard object ¿ no bone.Thereby the cutting edge was damaged and destroyed.Moreover, secondary cracks are visible resulting from too high torsional and/or bending forces during application.An additionally performed hardness measurement confirmed that the hardness values of the drill meet the specification.Based on investigation the root cause of the drill breakage was attributed to a user related handling issue.The drill breakage was caused due to a collision and impact with a hard material (no bone) during application.Indications for any material, manufacturing or design related problems were not determined in the investigation.
Event or Problem Description
It was reported that the drill broke off into the patient mandible intra-operatively.The broken piece was removed, and the surgery was completed successfully.

• Brand Name: 1.5X110MM DRILL, 20MM WL, COLOR DEPTH MARKS
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 10402954
• Report Number: 0008010177-2020-00040
• Device Sequence Number: 3669058
• Product Code: HBE
• UDI-Device Identifier: 04546540695086
• UDI-Public: 04546540695086
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K070876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020

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: 60-15620
• Device Catalogue Number: 60-15620
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1