MAUDE Adverse Event Report: BIOMET MICROFIXATION MOSQUITO FCPS RIGHT ANG 11.5CM; FORCEPS, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2022

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported that the instrument was discovered fractured during a routine inspection.There was no patient injury as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the returned forceps.The forceps shows signs of multiple uses including heavy marking/ scratching on the instrument surface.One of the two tips has fractured at the base of the tip where it meets the forcep body.The fractured tip was not returned.The complaint is confirmed.A determination cannot be made as to what caused the tip to fracture.A device history review was not conducted as the engraved date code corresponds to a manufacturing date of july-dec 2005.The device has an estimated field age of 17 years.The device shows signs of multiple uses and there was no reported patient harm.A definitive root cause cannot be determined.If any further information is found 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 furhter event information is available at teh time of this report.

• Brand Name: MOSQUITO FCPS RIGHT ANG 11.5CM
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15371981
• MDR Text Key: 299895047
• Report Number: 0001032347-2022-00294
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 03-0064
• Device Lot Number: CU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Female