MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5 MM SYSTEM TWIST DRILL .8X50MM 7MM STOP 1.0; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the drill tip fractured while drilling the pilot hole and about a 5mm drill tip remains in the body.The surgeon plans to remove the drill tip at least a month after the bone has healed.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the returned twist drill.The drill shows sings of use including marking on the drill body.The drill has fractured where the drill flutes meet the drill base.The complaint is confirmed.A determination cannot be made as to what caused the drill to fracture.Review of the cert identified no deviations or anomalies during manufacturing.The supplier dhr was not requested because the raw material certificate showed material is conforming to specification and no problems were found after the return of the devices.The dhr was not reviewed as zimmer lot is for packaging purposes only and the complaint is not related to a packaging related issue.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: metallic plate fixation of the left orbital floor is noted and a small drill tip fragment is present at the medial orbital floor.Additional plates and screws are present.No displacement of the fractures is seen and alignment of the post-operative facial bones appears anatomic.Bone quality appears unremarkable.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.This report is being submitted to update additional information in section b4, b5, d9, g3, g6, h2, h3, h4, h6 and h10.Correction is in section d4.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 1.5 MM SYSTEM TWIST DRILL .8X50MM 7MM STOP 1.0
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: christina arnt ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 13934487
• Report Number: 0001032347-2022-00099
• Device Sequence Number: 14635634
• Product Code: HBE
• UDI-Device Identifier: 00841036014247
• UDI-Public: (01)00841036014247(10)318282
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

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: 01-7428
• Device Lot Number: 318282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: Other
• Patient Sex: Unknown