MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MGII BONE SCREW DRILL; BIT, DRILL

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: nexgen 0 degree cut guide, catalog #: 00599707600, lot #: 60862407; mgii bone screw drill, catalog #: 00512008500, lot #: 65066200.The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.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 reports: 0001822565-2018-01969, 0001822565-2018-01970, 0001822565-2018-01971.

Event Description

It was reported that both drill bits got stuck in the cutting block and would not disengage.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Examination of the returned instruments determined that instruments have signs of repeated use (nicked, gouged, burrs) and 2 drill bits remain lodged in 2 of the pilot holes.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported event is attributed to wear and tear due to normal use.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: MGII BONE SCREW DRILL
• Type of Device: BIT, DRILL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7391593
• MDR Text Key: 104258119
• Report Number: 0001822565-2018-01971
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

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
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00512008500
• Device Lot Number: 62855176
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Initial Date Manufacturer Received: 03/07/2018
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: 05/15/2018
• Supplement Dates FDA Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 65 YR