MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNIVERSAL FMRL HD DRIVER; DRIVER, PROSTHESIS

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: 650-1057 ¿ ceramic head ¿ 0942910, 650-1066 ¿ ceramic taper - 2936763.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 was reported that during impaction of the femoral head, two plastic pieced broke off the impactor.None of the pieces were retained by the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual examination identified that the head of the instrument was fractured and the fracture originated at the threaded section.The head remains in the single piece.Impact marks were identified on the rim of the head and the strike plate of the handle.The distal end of the handle¿s shaft was scuffed.Damage consistent with multiple use were identified.Dimensional analysis of the screw determined that the screw¿s overall length was conforming to print specifications.The screw was initially loose when the device was returned.Dhr was reviewed and no discrepancies were found.Root cause was unable to 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 additional event information to report at this time.

• Brand Name: UNIVERSAL FMRL HD DRIVER
• Type of Device: DRIVER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8181169
• MDR Text Key: 131175668
• Report Number: 0001825034-2018-11454
• Device Sequence Number: 1
• Product Code: HWR
• 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: 07/30/2019

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 Model Number: N/A
• Device Catalogue Number: 31-476946
• Device Lot Number: 057630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 07/25/2019
• Supplement Dates FDA Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention