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 Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).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.Concomitant medical products- zimmer biomet contra angle blade catalog #: sp-2379 lot #: unknown.
Event or Problem Description
It was reported that the driver broke as the surgeon was placing a 3rd rib posterior screw during a procedure for the repair of a rib fracture.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.Complaint sample was evaluated and the reported event was confirmed.The driver and blade were returned for investigation.The driver showed signs of use with some minor scratching and discoloration on the handle and knob.The driver was also returned with the blade stuck inside the collet, which showed signs of use with nicks and scratches on the exposed surfaces, likely resulting from an attempt to extract the blade from the driver.Functional testing was done by attempting to remove the blade; the blade could not be removed.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to a blade mating issue, as this driver was manufactured before the implementation of the scar addressing the blade getting stuck inside the driver.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: date of this report, describe event or problem, lot number, device availability, date received by manufacturer, type of report, follow up type, device evaluated by manufacturer, device manufacturer date, method code, results code, conclusions code, additional narratives/data.

• 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: 8599620
• Report Number: 0001032347-2019-00274
• Device Sequence Number: 16639622
• Product Code: HRS
• UDI-Device Identifier: 00841036123130
• UDI-Public: 00841036123130
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K142823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

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: 24-1189
• Device Lot Number: 861240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 07/22/2019
• 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