MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED DRILL BIT; SURGICAL ORTHOPEDIC INSTRUMENT

Model Number	DIAMETER 3 MM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
Event or Problem Description
During drilling the inferior peripheral hole for the baseplate fixation: the drill bit broke off and has been left inside the patient.

• Brand Name: AEQUALIS REVERSED DRILL BIT
• Common Device Name: SURGICAL ORTHOPEDIC INSTRUMENT
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 8128333
• Report Number: 3000931034-2018-00156
• Device Sequence Number: 13847781
• Product Code: HWE
• UDI-Device Identifier: 03700386968709
• UDI-Public: 03700386968709
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2018

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: DIAMETER 3 MM
• Device Catalogue Number: MWB107
• Device Lot Number: 15B785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 12/04/2018
• 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: Other