MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 0 MM RASP LONG POST; INSTRUMENT, HIP

Catalog Number 00771200464

Device Problem Fracture (1260)

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

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Report source: (b)(6).

Event Description

It was reported that during a hip surgery, the tip of the broach fractured off while impacting.All fractured pieces were removed from the patient's wound and no pieces were retained.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) 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: 0 MM RASP LONG POST
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10778900
• MDR Text Key: 214362805
• Report Number: 0001822565-2020-03699
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00771200464
• Device Lot Number: 62808427
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 03/04/2021
• Supplement Dates FDA Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1