MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 2.5 MM HEX CANNULATED SCREWDRIVER; SURGICAL INSTRUMENT

Catalog Number 00236016625

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source - (b)(6).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

Hold for r.G.1.20 it was reported that the hex tip of the driver snapped off while driving the screw into the plate.There was a surgical delay of fifteen minutes.No adverse event has been reported as a result of the malfunction.

Event Description

No additional event information is available at the time of this report.

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.Visual examination of the returned product identified that the hex tip was fractured.Hardness testing found that the material was within specifications.Device history record (dhr) 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.

Event Description

No additional event information is available at the time of this report.

• Brand Name: 2.5 MM HEX CANNULATED SCREWDRIVER
• Type of Device: SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11172991
• MDR Text Key: 228350722
• Report Number: 0001822565-2021-00160
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2021

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: 00236016625
• Device Lot Number: 60691292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 04/16/2021; 04/26/2021
• Supplement Dates FDA Received: 04/28/2021; 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1