MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR FLEX DRILL BIT 3.2 MM DIAMETER 45 MM LENGTH; BIT, DRILL

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign report source: (b)(6).Concomitant medical products: 00879000705 4502359749 flexible shaft, tri-shank.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03941.
Event or Problem Description
It was reported that during surgery, the instrument was fractured.Patient involvement is unknown.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Complaint samples were evaluated and the reported event was confirmed.Visual evaluation identified the following: both drill bits were fractured at approximately.800" from the drill point.The cutting edges were dull and damaged, indicative of previous usages.The 30mm drill bit has had a potential field age of approximately 3 years 2months and the 45mm drill bit has had a potential field age of approximately 4 years 7 months.No other damages were noted.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: MODULAR FLEX DRILL BIT 3.2 MM DIAMETER 45 MM LENGTH
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10905015
• Report Number: 0001822565-2020-03940
• Device Sequence Number: 16509510
• Product Code: HTW
• UDI-Device Identifier: 00889024152229
• UDI-Public: (01)00889024152229
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: 00879000704
• Device Lot Number: 63285580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 03/30/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE