MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM DRILL, 1.6X50MM 22MM STOP; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The device will not be returned for analysis as it was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.The user facility is foreign; therefore, a facility medwatch report will not be available.(b)(6).
Event or Problem Description
It was reported the drill fractured during a procedure.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following fields were updated: b4 date of this report b5 describe event or problem d4 serial number d4 lot number - based on a review of inventory transactions and this customer's purchase history, there are seven five (5) possible lots: 229250 490150 418090 605310 714350 g4 date received by manufacturer g7 type of report h2 if follow-up, what type h4 device manufacturer date h10 additional narratives/data.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
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 cannot be verified.Functional testing and inspections could not be performed due to the product not being returned and no photographs being provided.The certs were reviewed and there were no non-conformances found.There are no indications of manufacturing defects.Complaint history for 46-1006 vendor lot 327136 was reviewed for similar complaints, leading to a complaint rate of 0.02% which is no greater than the occurrence listed in the application fmea.The most likely underlying 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.The following fields were updated: b4 date of this report; b5 describe event or problem; g4 date received by manufacturer; g7 type of report; h2 follow up type; h3 device evaluated by manufacturer; h6 method code; h6 results code; h6 conclusions code; h10 additional narratives/data.

• Brand Name: TRAUMAONE SYSTEM DRILL, 1.6X50MM 22MM STOP
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10369149
• Report Number: 0001032347-2020-00358
• Device Sequence Number: 972444
• Product Code: HBE
• UDI-Device Identifier: 00888233009522
• UDI-Public: 00888233009522
• 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,Followup
• Report Date (Section B): 10/16/2020

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: 46-1006
• Device Lot Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 08/19/2020; 10/15/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 08/24/2020; 10/16/2020
• 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