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

Catalog Number 904755

Device Problem Fracture (1260)

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

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign: (b)(6).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

It was reported that the traction wire of the ziploop is auto split during a slight traction.There was no reported patient injury.

Manufacturer Narrative

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

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

• Brand Name: #7 PE ZIPLOOP EXT TOGGLELOC
• Type of Device: FASTNER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12188701
• MDR Text Key: 262204584
• Report Number: 0001825034-2021-02127
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00880304453354
• UDI-Public: (01)00880304453354
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K130033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 904755
• Device Lot Number: P15593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose