MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 7MM BONE DOWEL COLLET; TRAUMA, INSTRUMENT

Catalog Number 900717

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 09/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fda product code: hwk.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.Product not returned.

Event Description

It was reported that the instrument fractured during use.Another instrument was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The fractured piece named slider in the photos is from the body of the slider.It appears that a dowel pin has sheared inside the body that holds the shank in place and allowed the shank to move inside of the slider allowing the bearings to pop out of the collar and fracture.The dowel pins lock the shank from rotating and the returned instrument does rotate slightly.The fractured slider is missing a small piece that was not 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.

Event Description

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

• Brand Name: 7MM BONE DOWEL COLLET
• Type of Device: TRAUMA, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7925705
• MDR Text Key: 122633841
• Report Number: 0001825034-2018-09321
• Device Sequence Number: 1
• Product Code: HWK
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 900717
• Device Lot Number: 039890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1