MAUDE Adverse Event Report: BIOMET MICROFIXATION MODIFIED BECK ELEVATOR; INSTRUMENT

Catalog Number SP-2359

Device Problem Fracture (1260)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00035, 0001032347-2021-00041, 0001032347-2021-00042.Concomitant medical products: item# sp-2359 modified beck elevator; lot# unknown.Item# sp-2359 modified beck elevator; lot# unknown.Item# sp-2359 modified beck elevator; lot# unknown.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

It was reported that same item continues to break.Four (4) item had broken during use by same physician over a period of six (6) months.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual evaluation noted the tip of the instrument is fractured.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.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 available at the time of this report.

• Brand Name: MODIFIED BECK ELEVATOR
• Type of Device: INSTRUMENT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11272319
• MDR Text Key: 230041968
• Report Number: 0001032347-2021-00043
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

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: SP-2359
• Device Lot Number: 021020B20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1