MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM DRILL, 1.6X115MM 26MM STOP DRILL; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical product - zimmer biomet traumaone system drill, catalog #: 46-1006, lot #: ni; unknown plate, catalog#: ni lot#: ni; unknown screw, catalog#: ni, lot#: ni.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00255.
Event or Problem Description
It was reported that two (2) drills fractured in the patient's mandible during a surgery for the repair of a mandibular fracture.The surgery was delayed one and a half hours due to additional time needed to remove the plate and screws, burr the patient's bone to remove the fractured piece, and replacement of the plate and screws.No additional patient consequences were reported.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.For this part (46-1007) and the previous one year (from the notification date), there is a complaint rate of 0.05% which is no greater than the occurrence listed in the application fmea.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TRAUMAONE SYSTEM DRILL, 1.6X115MM 26MM STOP DRILL
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8560986
• Report Number: 0001032347-2019-00256
• Device Sequence Number: 2346417
• Product Code: HBE
• UDI-Device Identifier: 00841036137427
• UDI-Public: 00841036137427
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K062842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2019

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: N/A
• Device Catalogue Number: 46-1007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention