MAUDE Adverse Event Report: BIOMET MICROFIXATION 90° CONTRA ANGLE DRIVER; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The user facility is foreign; therefore, a facility medwatch report will be available.Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the driver failed to tighten a screw during a rib plating case.Once the device stopped working, it could no longer be used during surgery.There was a two to four minute surgical delay due to the failure of the instrument and having to use an alternative instrument.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.Reported event was unable to be confirmed due to limited information received from the customer.The contra angle screwdriver was not returned for investigation and no photos were provided.For these reasons, the driver could not be visually evaluated or functionally tested.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.It is possible that excessive force was applied, which stripped the gears.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
This follow-up report is being submitted to relay additional information.
Event or Problem Description
This follow-up report is being submitted to relay corrected information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.

• Brand Name: 90° CONTRA ANGLE DRIVER
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8612677
• Report Number: 0001032347-2019-00280
• Device Sequence Number: 14074231
• Product Code: HRS
• UDI-Device Identifier: 00841036123130
• UDI-Public: 00841036123130
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K142823
• 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,Followup
• Report Date (Section B): 02/21/2020

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: 24-1189
• Device Lot Number: 474720
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 07/16/2019; 07/16/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 07/22/2019; 02/21/2020
• 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