MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OFFSET FLEX CLAMP BROACH HNDL; INSTRUMENT, HIP

Catalog Number 31-555408

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in the 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 during an initial hip procedure the taperlock handle broke while impacting the broach.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not be determined as the necessary information to adequately investigate the reported event was not 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: OFFSET FLEX CLAMP BROACH HNDL
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11176769
• MDR Text Key: 228238452
• Report Number: 0001825034-2021-00062
• Device Sequence Number: 1
• Product Code: LXH
• 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,health profession
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 31-555408
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 113