MAUDE Adverse Event Report: BIOMET MICROFIXATION ELEVATOR #301; INSTRUMENT, MICROFIXATION

Catalog Number 09-0257

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00064.Concomitant products: item# unk 301 elevator ; lot# unk 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.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

It was reported approximately three (3) weeks ago, that the device had broken on an unknown date.No harm or consequences to the patient have been reported.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is still ongoing.Once the investigation has been completed, a follow-up mdr will be submitted.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.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d4; d9; g3; g6; h1; h2; h3; h6.D4: lot # updated to - 080719g19.Visual examination of the returned product identified: quantity of one elevator was returned for evaluation.Visual inspection identified the lot number, as well as found the tip to be fractured.Medical records were not provided.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 which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ELEVATOR #301
• Type of Device: INSTRUMENT, MICROFIXATION
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11308909
• MDR Text Key: 232542683
• Report Number: 0001032347-2021-00063
• 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: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2021

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: 09-0257
• Device Lot Number: 080719G19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 02/11/2021; 07/20/2021
• Supplement Dates FDA Received: 02/16/2021; 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: ITEM# 09-0257, LOT# UNK; SEE NARRATIVE IN H10