MAUDE Adverse Event Report: BIOMET MICROFIXATION UNK WIRE; PROSTHESIS, MICROFIXATION

Catalog Number UNK WIRE

Device Problems Fracture (1260); Unstable (1667)

Patient Problem Failure of Implant (1924)

Event Date 02/22/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00119 0001032347-2021-00121 0001032347-2021-00123 item# 73-2634; lot# unk item# unk wire; lot# unk item# unk 16mm screw; lot# unk item# unk 18mm screw; lot# unk customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was requested but not returned by the hospital.The investigation is in process.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 that the patient was originally implanted approximately three (3) weeks ago.Subsequently, the patient was revised three (3) days post-implantation due to instability.During the revision, it was found the wires were fractured and the plate was loose.The screws were removed and reused with the new implant.Attempts have been made and no further information has been provided.

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.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.

Event Description

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

• Brand Name: UNK WIRE
• Type of Device: PROSTHESIS, MICROFIXATION
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11494627
• MDR Text Key: 240046674
• Report Number: 0001032347-2021-00120
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• PMA/PMN Number: NI
• 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: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK WIRE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 08/06/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR