MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM ANKLE ADJUSTABLE U FRAME; PROSTHESIS, ANKLE

Model Number N/A

Device Problems Material Twisted/Bent (2981); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.(b)(4).(b)(6).

Event Description

It was reported that during an ankle procedure, when the surgeon attempted to use the u frame, the tma lateral cutting guide was difficult to slide onto the frame rod.It was reported the frame may be bent.There were no adverse events to the patient.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.A video was provided from the distributor demonstrating the malfunction, and the device was returned for evaluation.Two of the frames that were returned had a slight wobble when rolled on a surface plate, which indicates that they are bent.All of the returned frame rods exhibit wear marks.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definite root cause cannot be determined with the information provided.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: TM ANKLE ADJUSTABLE U FRAME
• Type of Device: PROSTHESIS, ANKLE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7958427
• MDR Text Key: 123517890
• Report Number: 0001822565-2018-05675
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: PK120906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

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 Model Number: N/A
• Device Catalogue Number: 00450105002
• Device Lot Number: 63233599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 10/11/2018
• Supplement Dates Manufacturer Received: 03/20/2019
• Supplement Dates FDA Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1