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

Model Number N/A

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2017

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Report source: foreign country (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.

Event Description

It was reported during a rib fixation on the left side the contra angle screwdriver showed a working failure during the insertion of a screw.The screwdriver blade didn¿t respond anymore when the surgeon was turning at the distal end.The surgeon could proceed without any major issues.There was no impact on the patient.No adverse events have been reported as a result of the malfunction.

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.Product identities could not be confirmed due to the products not being returned.Since the products were not returned, visual inspection and functional testing could not be performed, therefore the complaint could not be verified and the most likely underlying cause could not be determined.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Zimmer biomet will continue to monitor for trends.This event and another event (report # 0001032347-2018-00049) were reported for the same part and lot number (catalog #: 24-1189 lot #: 308810).Both drivers were returned to zimmer biomet (b)(4), however one of the drivers is unable to be located.Since it is unable to be determined which event the driver belongs to, the driver will be evaluated and the evaluation results will be reported in both files.This report is to capture the driver which was not received for evaluation.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.A visual inspection of the returned contra angle driver shows good overall condition as there are only minor scratches and discoloration noted.It was reported that "the screwdriver blade didn¿t respond anymore when the surgeon was turning at the distal end." when rotating the distal end of the driver, there was frequent sticking and clicking noted.A functional testing was attempted using a contra angle traumaone blade, cross-drive (part #sp-2379) to drive a 2.4 x 20 mm screw (part #73-2416) into a block of poplar wood.However, the screw could not be inserted.The complaint is considered confirmed.The screwdriver was disassembled for further investigation and inspection; it was noted that the internal gears were stripped and there were metal shavings during the disassembly.The most likely underlying cause of this complaint is the gears being stripped, likely a result of excessive force from over torqueing by the surgeon.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to excessive force.A summary of the investigation has been sent to the complainant.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.

• Brand Name: 90 DEGREE CONTRA ANGLE DRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7218609
• MDR Text Key: 98424243
• Report Number: 0001032347-2018-00050
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PK142823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 24-1189
• Device Lot Number: 308810
• Other Device ID Number: (01)00841036123130(10)308810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Date Manufacturer Received: 06/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIOMET MICROFIXATION BLADE CATALOG #: NI LOT #: NI.