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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported that surgeon tried to remove the rasp in the humeral canal and the instrument broke.The patient did not retain a foreign body.No further information available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Corrected: no adverse event has occurred as a result of this malfunction visual examination confirms the reported material fracture.Dimensional analysis confirms the device conforms to its specifications.Review of device history records found these units were released to distribution with no deviations or anomalies.Root cause is unknown.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 information available at the time of this reporting.

• Brand Name: COMP BROACH EXTRACTOR TOOL TOOL
• Type of Device: EXTRACTOR
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9175367
• MDR Text Key: 161929073
• Report Number: 0001825034-2019-04555
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 00880304456808
• UDI-Public: 00880304456808
• 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: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• 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: 179740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention