MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG TWIST DRILL, DIAM.1.6X125MM, WL 50MM, STRYKER SHAFT END, MANDIBULAR LAG SCREWS; INSTRUMENT

Catalog Number	60-16050
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received at the manufacturer for testing.An evaluation will be conducted, 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 tip fractured off during a case and fall into patient.The procedure was delayed over 45-60 minutes for the x-ray to recover and remove it from the patient.
Event or Problem Description
It was reported that the twist drill tip fractured off during a case and fall into patient.The procedure was delayed over 45-60 minutes for the x-ray to recover and remove it from the patient.
Additional Manufacturer Narrative
The reported event that the tip of the drill fractured could be confirmed.The visual inspection revealed that drill helix is broken off near the shaft at the working area.The broken off fragment could be retrieved and was returned.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 , not bone.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.Therefore, no corrective and/or preventive actions are deemed to be necessary at this time.

• Brand Name: TWIST DRILL, DIAM.1.6X125MM, WL 50MM, STRYKER SHAFT END, MANDIBULAR LAG SCREWS
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 8147932
• Report Number: 0008010177-2018-00113
• Device Sequence Number: 13847934
• Product Code: HBE
• UDI-Device Identifier: 04546540356529
• UDI-Public: 04546540356529
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 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: 60-16050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2018
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/10/2018
• 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