MAUDE Adverse Event Report: BIOMET MICROFIXATION "1.5MM" 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	No Information (3190)
Date of Event	02/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical product - unknown biomet microfixation driver, catalog #: ni, lot #: ni.The user facility is foreign; therefore a facility medwatch report will not be available.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the new drill bit fractured after drilling greater than 20 holes during an operation for a patient who experienced trauma.There was no patient injury but this issue did delay the surgery approximately half an hour or so as the surgeon had to remove the broken part from the patient and needed to get a new drill bit to complete the procedure.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.Reported event was confirmed by review of the product photograph provided.The drill was not returned for investigation; a photo was provided and the drill was clearly fractured near the area where the fluted section begins.The complaint is confirmed.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to excessive force being applied during use, beyond what the instrument was designed to encounter.There are no indications of manufacturing defects.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 ifu for this product (ifu for twist drill (01-50-1260)_reve) states in the section titled 'warnings and precautions': intraoperative fracture or breaking of twist drills has been reported.The manufacturer's instructions for the hand piece must be followed while using the twist drill.The maximum recommended speed is 40,000 rpm in order to avoid failures such as breakage of the twist drill.Insure drill is fully seated in handpiece prior to use.Twist drill should not be revved prior to contact with bone.Excessive force may cause unusual stress conditions and result in breakage or fracture of the device.

• Brand Name: "1.5MM" 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: 8523034
• Report Number: 0001032347-2019-00232
• Device Sequence Number: 2672025
• Product Code: HBE
• UDI-Device Identifier: 00841036013189
• UDI-Public: 00841036013189
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K062842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2019

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: 511850
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 07/24/2019
• 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: Required Intervention