MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 9MM STOP; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).The device will not be returned for analysis as it was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Occupation: purchasing assistant specialist.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source ¿ (b)(6).
Event or Problem Description
It was reported the drill fractured and resulted in the retention of a foreign body during a procedure on a left orbital fracture.The surgeon placed orbital mesh and was affixing a suture to the fractured bone when the drill fractured.The piece of the fractured drill could not be removed.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is considered to be confirmed because it was reported that additional imaging and a consultation were conducted.The tw drill 1.1x50mm 9mmstop w/nt (item# 01-7146, lot# 834540) was not returned for investigation and no photos, scans, x-rays, or physician's reports were provided.For these reasons, no functional testing or visual evaluation could be conducted.The cert was reviewed and there were no non-conformances found.There are no indications of manufacturing defects.This is the only complaint for this item# 01-7146, vendor lot# 834540.The most likely underlying cause of the complaint is excessive force was applied, beyond what the drill was designed to encounter.It is possible that the drill was used over its maximum recommended speed, it was used to drill into high density bone, excessive normal force was applied during drilling, or off-axis forces were applied during drilling.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.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following fields were updated: date of this report.Describe event or problem.Relevant tests/laboratory data.Date received by manufacturer.Type of report.Follow up type.Additional narratives/data.
Event or Problem Description
It was reported the drill fractured and resulted in the retention of a foreign body during a procedure on a left orbital fracture.The surgeon placed orbital mesh and was affixing a suture to the fractured bone when the drill fractured.A fluoroscopy was performed and an x-ray imaged a millimetric foreign body inside the bone.Following an ent consultation, it was determined that the retained foreign body did not pose a threat to the patient¿s health.The millimetric fractured tip of the drill was not removed from the maxilla bone.No additional patient consequences have been reported.

• Brand Name: 1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 9MM STOP
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10482087
• Report Number: 0001032347-2020-00408
• Device Sequence Number: 4093324
• Product Code: HBE
• UDI-Device Identifier: 00841036013189
• UDI-Public: 00841036013189
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K062842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2020

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: 01-7146
• Device Lot Number: 834540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/22/2020
• Supplement Date Received by Manufacturer: 09/26/2020; 10/28/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 10/05/2020; 11/06/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention