MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG TWIST DRILL, DIAM. 1.9X58MM, FOR 6+7MM SCREW LENGHT, STRYKER SHAFT END; INSTRUMENT

Model Number	92-19758
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	08/03/2020
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 twist drill broke intra-operatively.A backup drill was used to successfully complete the case.
Additional Manufacturer Narrative
The reported event of a drill breakage could be confirmed.The visual inspection revealed that the drill helix of the returned drill has been broken off near the shaft.The broken off fragment could not be retrieved and was not returned.Within the microscopic investigation at the fracture area plastic deformations and typical secondary cracks are visible resulting from too high torsional and/or bending forces during application.Furthermore, the fracture surface shows the appearance of a ductile forced rupture also caused by too high torsional and/or bending forces.Moreover, in order to check the hardness of the drill a hardness measurement was performed.The measured hardness values of the returned drill meet the specification.Based on the investigation the root cause of the drill breakage was attributed to a user related issue due to applying too high forces 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 twist drill broke intra-operatively.A backup drill was used to successfully complete the case.

• Brand Name: TWIST DRILL, DIAM. 1.9X58MM, FOR 6+7MM SCREW LENGHT, STRYKER SHAFT END
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 10402960
• Report Number: 0008010177-2020-00041
• Device Sequence Number: 3669061
• Product Code: HBE
• UDI-Device Identifier: 07613154629442
• UDI-Public: 07613154629442
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• 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: 92-19758
• Device Catalogue Number: 92-19758
• 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: 08/03/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• 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