MAUDE Adverse Event Report: BIOMET MICROFIXATION PERIOSTEAL ELEVATOR #853; INSTRUMENT

Catalog Number 09-0386

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

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.

Event Description

The customer reported item was broken.It was reported that it was noticed that item was broken while cleaning the instrument.It was reported that item was not broken during surgery and there was no patient involvement.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.If any further information which would change or alter any conclusions or information, a supplemental report 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.

Manufacturer Narrative

One item# 09-0386 lot# 080719g19 was returned and verified per etch.Visual examination of product identified noticeable burnishing wear from repeated use of the middle handle on the large spatula end of the instrument.This is the same end of the middle handle in which the crack was identified.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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 is available at this time.

• Brand Name: PERIOSTEAL ELEVATOR #853
• Type of Device: INSTRUMENT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11281304
• MDR Text Key: 230627670
• Report Number: 0001032347-2021-00056
• Device Sequence Number: 1
• Product Code: EMJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/18/2021

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: 09-0386
• Device Lot Number: 080719G19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 02/24/2021; 06/17/2021
• Supplement Dates FDA Received: 02/26/2021; 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1