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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.The lot number 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: 895770, 604330, 490830, 472910 multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00190 medical products traumaone system drill, 1.6x115mm 26mm stop, part# 46-1007, serial# 327137, potential lot numbers# 895770, 604330, 490830, 472910.(b)(6).
Event or Problem Description
It was reported two (2) drill bits fractured while transplanting the fibula during reconstruction of the mandible.The broken tip was removed from the patient¿s body.It was reported that no further information was available.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
The two (2) drill 1.6x115mm 26mm stop (item# 46-1007, lot# 327137) were returned for investigation.It was determined that the '327137' etched on the body of these drills is the vendor's lot.Based on a review of inventory transactions and the customer's purchase history, there are 4 possible zimmer biomet lots: 895770, 604330, 490830, or 472910.Visual examination of the returned drills confirmed the products' identity.It was also confirmed that the drills were fractured, near the neck at the start of the fluted section.Review of the device history records identified no deviations or anomalies during manufacturing.The supplier dhr was not requested because the raw material certificate showed material is conforming to specification, including the material hardness.A definitive root cause cannot be determined.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
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11648105
• Report Number: 0001032347-2021-00189
• Device Sequence Number: 3355977
• Product Code: HBE
• UDI-Device Identifier: 00841036137427
• UDI-Public: (01)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): 07/14/2021

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: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 07/16/2021
• 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