MAUDE Adverse Event Report: ZIMMER BIOMET, INC. #7 PE ZIPLOOP EXT TOGGLELOC; PROSTHESIS, SPORTSMED

Model Number N/A

Device Problem Fracture (1260)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign: event occurred in (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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

It was reported that the wire of the ziploop toggleloc fractured.Attempts have been made and additional information on the reported event is unavailable at this time.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

A couple of sutures and a ti button were provided for evaluation; visual inspection identified the suture is broken.Additional information does not change the root cause of the previous investigation.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 additional information reported.

• Brand Name: #7 PE ZIPLOOP EXT TOGGLELOC
• Type of Device: PROSTHESIS, SPORTSMED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9239163
• MDR Text Key: 196269828
• Report Number: 0001825034-2019-04845
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00880304453364
• UDI-Public: (01)00880304453364
• Combination Product (y/n): N
• PMA/PMN Number: K120906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 904755
• Device Lot Number: P07854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1