MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DRILL PIN AND SCREW INSERTER; EXTRACTOR

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that the pin driver was broken while pulling the pins out, and the broken piece was retrieved.Attempts have been made and additional information on the reported event is unavailable.

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.

Manufacturer Narrative

Udi # - (b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned part indicates that the device exhibits signs of repeated use and the tip of the driver has fractured off.Dimensional examination indicates that the driver conforms to the measurable print specifications.Sem analysis indicates that the driver fractured due to overload.Quasi-cleavage mode of fracture identified throughout the fracture surface.Fracture surface revealed multiple crack exit sites near the outer diameter of the pin driver and that indicates the cracks propagated towards its outer diameter after initiating near the inner diameter of the driver.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: DRILL PIN AND SCREW INSERTER
• Type of Device: EXTRACTOR
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7590463
• MDR Text Key: 110703677
• Report Number: 0001822565-2018-03072
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• 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: 00590102100
• Device Lot Number: 63373630
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 78