MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 2.7MM CALIB DRILL BIT; INSTRUMENT/TRAUMA

Model Number	2142-27-070
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the instrument was stuck in the guide during surgical procedure.There was no report of foreign body retained or harm to patient.Once product was investigated it was found to be fractured while stuck in guide.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item#: 214207027, 2.7mm locking drill guide; lot#: c1xpf4.(b)(4).Visual examination of the returned product identified the drill bit was stuck within the guide and cannot be removed by hand.The drill bit also had fractured and not all the pieces were returned.Dimensional analysis of the drill bit diameter was taken and found to be conforming to print specifications.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 2.7MM CALIB DRILL BIT
• Common Device Name: INSTRUMENT/TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15690423
• Report Number: 0001825034-2022-02420
• Device Sequence Number: 6821926
• Product Code: HTW
• UDI-Device Identifier: 00887868024955
• UDI-Public: (01)00887868024955(11)210604(10)ZB6939284
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/28/2022

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: 2142-27-070
• Device Catalogue Number: 214227070
• Device Lot Number: ZB6939284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• 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: 09/30/2022
• Initial Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female