MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0MM SYSTEM TWIST DRILL WITH J NOTCH; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00533, 0001032347-2019-00535, 0001032347-2019-00536.Medical products: 2.0mm system twist drill with j notch, part# 01-9198, lot# 753330, 2.0mm system twist drill with j notch, part# 01-9198, lot# unknown, 2.0mm system twist drill with j notch, part# 01-9203, lot# unknown, 2.0mm system twist drill with j notch, part# 01-9203, lot# unknown.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 four drill bits fractured during surgery.In two of the drill bits, the fractured pieces were difficult to remove and the bone was scraped in order to facilitate removal.All pieces of fractured drill bits were removed from the patient and no foreign body remained in the patient.No additional patient consequences were reported.
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 complaint is confirmed.On visual inspection, the drill was noted to have a transverse fracture through the flutes near the drill neck.The non-conformance database was reviewed for 01-9198 lot 532047 and no non-conformances were found.There are no indications of manufacturing defects.Complaint history for 01-9198 lot 532047 was reviewed, and, for this lot regarding similar complaints, there is a complaint rate of (b)(4) which is no greater than the occurrence listed in the application fmea.For this part (01-9198) and the previous one year (from the notification date) regarding the fracturing of this drill, there is a complaint rate of(b)(4) which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint is the drill experienced force in excess of what it was designed to encounter; fractures at this point of the drill are typical of excessive force fractures.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.The following fields were updated: b4 date of this report, b5 describe event or problem, d10 device availability, g4 date received by manufacturer, g7 type of report, h2 follow up type, h3 device evaluated by manufacturer, h6 method code, h6 results code, and h6 conclusions code h10 additional narratives/data.

• Brand Name: 2.0MM SYSTEM TWIST DRILL WITH J NOTCH
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9428508
• Report Number: 0001032347-2019-00534
• Device Sequence Number: 16571826
• Product Code: HBE
• UDI-Device Identifier: 00841036016982
• UDI-Public: 00841036016982
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2020

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: 01-9198
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/17/2019
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 05/28/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention