MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5 MM SYSTEM LARGE HEX DRILL 1.1 MM X 67 MM W/ 5 MM STOP STAINLESS STEEL

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, the surgeon does not wish to return it.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 the drill fractured during a left frontal exereses/ during flap fixation.The surgeon was able to remove all parts of the drill.The procedure was completed with a new drill.No adverse events have been reported as a result of the malfunction.
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 unable to be confirmed due to limited information received from the customer.The distributor reported the surgeon did not wish to return the drill for evaluation.No product was returned and no functional tests or inspections could be performed.No pictures were provided.For these reasons, the complaint could not be verified.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: 1.5 MM SYSTEM LARGE HEX DRILL 1.1 MM X 67 MM W/ 5 MM STOP STAINLESS STEEL
• Common Device Name: DRILL
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8436954
• Report Number: 0001032347-2019-00179
• Device Sequence Number: 11319731
• Product Code: HBE
• UDI-Device Identifier: 00841036073930
• UDI-Public: 00841036073930
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

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: 15-1725
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR