MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE BROACH EXTRACTOR TOOL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 06/28/2018

Event Type  Injury  

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.

Event Description

It was reported that a patient underwent a reverse total shoulder arthroplasty.During this procedure, while determining the size of the humeral component, the broach handle was dropped and was not able to be used to extract the broach provisional inside the patient.While trying to extract the broach, the surgeon broke the extractor piece.After the handle was flash sterilized, surgery was completed successfully.There was a 60 minute surgical delay.No further information is available at this time.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Broach extractor tool was returned for evaluation.As returned the tip of the device was fractured and was not returned.Device history record (dhr) was reviewed and no discrepancies were found.A definite root cause cannot be determined with the information provided.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: COMPREHENSIVE BROACH EXTRACTOR TOOL
• Type of Device: EXTRACTOR
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7779351
• MDR Text Key: 116996969
• Report Number: 0001825034-2018-05526
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 407393
• Device Lot Number: 683760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/03/2018
• Initial Date FDA Received: 08/13/2018
• Supplement Dates Manufacturer Received: 12/10/2018
• Supplement Dates FDA Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention