MAUDE Adverse Event Report: BIOMET MICROFIXATION DRILL, 1.6X115MM 26MM STOP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Lot number: through a review of inventory transactions and the customer's purchase history, four (4) potential lots were identified.390030, 542960, 394500, 394490.Medical product -unknown driver catalog#: ni lot#: ni.Report source- foreign:(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.Multiple mdr reports were filed for this event, please see associated reports:0001032347-2021-00394.
Event or Problem Description
It was reported that during an open reduction of a mandibular fracture, the drill fractured at the tip when the surgeon attempted to drill a pilot hole.There were no consequences or impact to the patient.It was reported that no further information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual evaluation of the drills shows that the bits fractured in the fluted section of the drill bits.The customer stated that the drills were used multiple times.The drills are single use devices.No other anomalies could be identified.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to a user error.The ifu for this device, ifu for twist drill (01-50-1260)_reve, states "device is single use only.Do not attempt to clean or re-sterilize this product.After use, this product may be a potential biohazard." 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.

• Brand Name: DRILL, 1.6X115MM 26MM STOP
• Common Device Name: DRILL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 12305016
• Report Number: 0001032347-2021-00395
• Device Sequence Number: 19762601
• Product Code: HBE
• UDI-Device Identifier: 00841036137427
• UDI-Public: 00841036137427
• 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): 08/27/2021

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 Model Number: N/A
• Device Catalogue Number: 46-1007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 08/27/2021
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE