MAUDE Adverse Event Report: BIOMET MICROFIXATION 90° CONTRA ANGLE DRIVER; SCREWDRIVER

Model Number	N/A
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Complaint sample was evaluated and the reported event was confirmed.The two (2) 90 degree contra angle screwdrivers (part# 24-1189, lot# 474730, 727920) were visually evaluated.The driver from lot# 727920 was returned with a contra angle blade (part# sp-2379) inside the collet.The two drivers showed signs of use with some minor discoloration on the handle and knob, likely resulting from repeated autoclave cycles.The drivers were functionally tested by rotating the knob in both the clockwise and counter-clockwise directions and were found to have some abnormal resistance during rotation.The drivers were disassembled for further inspection and it was found that the internal gears were stripped and metal shavings fell out during disassembly of both instruments.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to the gears being stripped, likely resulting from torque in excess of what is required to fixate the screw.In the warnings and precautions section of the instructions for use (ifu) for this product it is stated 'avoid undue stress or strain when handling or cleaning instruments.' the discoloration is most likely due to residual from the cleaning process.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.Multiple mdr reports were filed for this event; please see associated report: 0001032347-2018-00718-1.
Event or Problem Description
It was reported two right angle screwdrivers had trouble rotating during a rib fracture case.Additional screwdrivers were available to complete the case.No adverse events have been reported as a result of the malfunction.

• Brand Name: 90° CONTRA ANGLE DRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8375306
• Report Number: 0001032347-2019-00137
• Device Sequence Number: 16678733
• Product Code: HRS
• UDI-Device Identifier: 00841036123130
• UDI-Public: 00841036123130
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K142823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2019

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: 727920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1