MAUDE Adverse Event Report: BIOMET MICROFIXATION TOTAL MANDIBULAR SYSTEM 1.8X50MM DRILL, 26MM STOP; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).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 report: 0001032347-2020-00613.Lot number: the lot number provided by the customer is the vendor lot number.Based on a review of the vendor lots and the customer¿s purchase history, the following two (2) lot numbers are potential lot numbers: 201500, 054370.Medical products: total mandibular system 1.8x50mm drill, 26mm stop, part# 24-2050, lot# unk.Total mandibular system 1.8x50mm drill, 26mm stop, part# 24-2050, lot# unk.The user facility is foreign, therefore, a facility medwatch report will not be available.Foreign source: (b)(6).
Event or Problem Description
It was reported that two (2) drill bits fractured during a mandibular procedure.The surgeon reported the instruments shook during rotation.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).This follow-up report is being submitted to relay additional information.D4 ¿ the lot number (354507) etched on the product is the vendor's lot number.Following a review of production records and the customer's purchase history, the following four (4) lot numbers are potential zimmer biomet lot numbers: 054370, 201500, 423410, or 855320.It is unknown which exact device encountered this issue, it is one of the following: item#: 24-2050 lot#: 201500.Manufacture date: 14 jul 2020.Udi: (b)(4).Item#: 24-2050 lot#: 423410.Manufacture date: 22 mar 2021.Udi: (b)(4).Item#: 24-2050 lot#: 855320.Manufacture date: 10 may 2021.Udi: (b)(4).Visual examination of the returned product confirmed the products' identity.The drill was confirmed to be fractured, near the start of the fluted section of the drill.Both drills were confirmed to be fractured, near the start of the fluted section of the drill.One of the two fractured fluted sections also had a clear bend in it, but it could not be confirmed if the bend was on the drill from lot 354507 or 321017.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: TOTAL MANDIBULAR SYSTEM 1.8X50MM DRILL, 26MM STOP
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11051099
• Report Number: 0001032347-2020-00612
• Device Sequence Number: 11422111
• Product Code: HBE
• UDI-Device Identifier: 00841036059279
• UDI-Public: 00841036059279
• 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): 08/11/2021

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: 24-2050
• Device Lot Number: 054370
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/27/2020
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 08/11/2021
• 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
• Patient Age: 70 YR
• Patient Weight: 48