MAUDE Adverse Event Report: BIOMET MICROFIXATION CONTRA DRILL 1.5X15.5MM STP; INSTRUMENT, MICROFIXATION

Catalog Number	01-9181
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00583.Lot number given by reporter was the vendor lot number.There are 5 possible end-level lot numbers for this device: lot# m054140, lot# m101640, lot# m049140, lot# m659010, lot# m896130.Lot# m054140; device manufacturer date: 2020-07-16, lot# m101640; device manufacturer date: 2019-12-05, lot# m049140; device manufacturer date: 2019-11-27, lot# m659010; device manufacturer date: 2019-11-10, lot# m896130; device manufacturer date: 2019-07-17.Concomitant medical products: item# 01-9181; lot# 133310.Full establishment name: (b)(6) university.Foreign: event occurred in (b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported approximately seven (7) months ago, the drill fractured near the neck of the drill tip while drilling the mandible.The procedure was completed with an alternate drill bit.No adverse events have been reported as a result of the malfunction.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Two of item 01-9181 contra drill 1.5x15.5mm stp were returned.Visual evaluation of the drills shows that the bits fractured in the fluted section of the drill bits.No other anomalies could be identified.Device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: CONTRA DRILL 1.5X15.5MM STP
• Common Device Name: INSTRUMENT, MICROFIXATION
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 12083938
• Report Number: 0001032347-2021-00355
• Device Sequence Number: 3502842
• Product Code: HBE
• UDI-Device Identifier: 00841036016890
• UDI-Public: (01)00841036016890
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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: 01-9181
• Device Lot Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 07/07/2021
• 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: NI
• Patient Sequence Number: 1