MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEPHALOMEDULLARY FLEXIBLE CAPTURED SET SCREW DRIVER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 03/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign, event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device evaluated by manufacturer? not returned to manufacturer.

Event Description

It was reported the device fractured during the procedure while doctor was trying to insert the set screw.No further information is available at this time.

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.No device or images were received.Device history record (dhr) was reviewed and no discrepancies were found.A definitive root cause cannot 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 further event information available at the time of this report.

• Brand Name: CEPHALOMEDULLARY FLEXIBLE CAPTURED SET SCREW DRIVER
• Type of Device: DRIVER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8900871
• MDR Text Key: 154556940
• Report Number: 0001822565-2019-03511
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00249003507
• Device Lot Number: 62897914
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1