MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JIG BOLT DRIVER 8MM; INSTRUMENT, TRAUMA

Catalog Number 281013006

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign: (b)(6).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.Product not returned.

Event Description

It was reported that the instrument fractured during the procedure.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

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

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Visual examination of the returned product verified item and lot number.Item 281013006 has fractured at the tip and all the pieces were returned.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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: JIG BOLT DRIVER 8MM
• Type of Device: INSTRUMENT, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10643430
• MDR Text Key: 210250549
• Report Number: 0001825034-2020-03733
• Device Sequence Number: 1
• Product Code: HWR
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 02/18/2021

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: Health Professional
• Device Catalogue Number: 281013006
• Device Lot Number: 7324149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 10/08/2020; 02/17/2021
• Supplement Dates FDA Received: 10/28/2020; 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 19 YR