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

Model Number N/A

Device Problems Device Inoperable (1663); Separation Failure (2547)

Patient Problem No Patient Involvement (2645)

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

(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 the sales representative checked the set before delivering to another hospital for a case, and found that the contra angle screwdrivers did not work.One screwdriver was not turning smoothly, it is rough and hard to turn.The other screwdriver is getting harder to turn and after inserting a blade it could not be removed from the screwdriver.No patient involvement.

Manufacturer Narrative

Product has been received by zimmer biomet and the investigation is in process.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.Complaint sample was evaluated and the reported event was confirmed.The product identities were confirmed.Visual inspection of two 90 degree contra angle screwdrivers (part #24-1189, lot #580850) showed signs of moderate wear.One was sticking minimally and the other was tough to turn.Neither of the screwdrivers would release the blade head from the collet.The internal gears were found to be rusted and stripped.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to the blade connection issues that were due to the supplier using blades, and not the min/max gage, to design the collet resulting in the collet failing the max gage inspection.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° CONTRA ANGLE DRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7378238
• MDR Text Key: 103944339
• Report Number: 0001032347-2018-00151
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 24-1189
• Device Lot Number: 580850
• Other Device ID Number: (01)00841036123130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Date Manufacturer Received: 08/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1