MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG DRILL FOR 20MM, 1,5X107.5MM, STRYKER, STERILE; INSTRUMENT

Catalog Number	91-15920
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/15/2018
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.Please note, the actual quantity of affected devices is two.
Event or Problem Description
It was reported that two drills broke; one piece could not be retrieved and remained in-situ in the patient, and the other piece was retrieved.
Additional Manufacturer Narrative
The reported event that two pieces of the drill were broken off could be confirmed.Within the inspection it was visible that the drill helix was fractured in two pieces.One piece could be retrieved and was returned for investigation.Within the investigation it was determined that the cutting edges of the remaining drill helix as well as the broken off piece show strong damages and plastic deformations.Furthermore, the tip of the drill have been completely destroyed resulting from impacts with a hard material, not bone.Moreover, the fracture surface shows the appearance of a forced rupture resulting from torsional overload during application.Based on investigation the root cause of the drill helix breakage could be attributed to a user related issue.The breakage of the drill was caused by too high torsional forces during application due to impacts with a hard material (not bone).Indications for material, manufacturing or design related issues were not found within the investigation.
Event or Problem Description
It was reported that two drills broke; one piece could not be retrieved and remained in-situ in the patient, and the other piece was retrieved.

• Brand Name: DRILL FOR 20MM, 1,5X107.5MM, STRYKER, STERILE
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 8181092
• Report Number: 0008010177-2018-00114
• Device Sequence Number: 2111824
• Product Code: HBE
• UDI-Device Identifier: 04546540493712
• UDI-Public: 04546540493712
• Combination Product (Y/N): N
• PMA/510(K) Number: K070876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

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 Catalogue Number: 91-15920
• Device Lot Number: 6000075623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1