MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP BROACH EXTRACTOR TOOL TOOL; SHOULDER, INSTRUMENT

Catalog Number 407393

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 during the surgery, while extracting the broach from the patient humerus, the distal part of the extractor broke.

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.Udi: (b)(4).Report source : the event occurred in canada.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned product noted the product has fractured at the tip in two different locations.A hardness check noted the product is conforming.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: COMP BROACH EXTRACTOR TOOL TOOL
• Type of Device: SHOULDER, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8730270
• MDR Text Key: 149217409
• Report Number: 0001825034-2019-02732
• Device Sequence Number: 1
• Product Code: HWB
• 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
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 407393
• Device Lot Number: 475590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1