MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG TWIST DRILL FOR 6MM SCREWS, DIAM.1.35X50MM, WL 7MM, STRYKER-SHAFT; INSTRUMENT

Model Number	60-13506
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
Event or Problem Description
It was reported that the drill bit broke during drilling and a piece broke off and remains in patients sinus.
Additional Manufacturer Narrative
The broken off tip fragment of the drill was identified during the initial surgery but was removed during a second surgery and was returned for investigation.The broken shaft part of the drill was not returned and the visual inspection of the broken off tip fragment of the drill revealed damages on several areas.It was determined that the tip of the drill shows a blunt condition.According to this, plastic deformations in form of material bulging have occurred resulting from high torsional forces in combination with high axial pressure during drilling.Furthermore, it was found that the cutting edges at the tip fragment were also damaged resulting from friction and collision with a hard object, no bone).The fracture surface shows the appearance of a forced rupture caused by torsional overload.In summary, based on the investigation, the root cause of the drill breakage was caused by torsional overload which was attributed to an inappropriate user handling.
Event or Problem Description
It was reported that the drill bit broke during drilling and a piece broke off and remains in patients sinus.

• Brand Name: TWIST DRILL FOR 6MM SCREWS, DIAM.1.35X50MM, WL 7MM, STRYKER-SHAFT
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 11605657
• Report Number: 0008010177-2021-00019
• Device Sequence Number: 4216079
• Product Code: HBE
• UDI-Device Identifier: 04546540366498
• UDI-Public: 04546540366498
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

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 Model Number: 60-13506
• Device Catalogue Number: 60-13506
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention