MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TOGGLELOC WITH ZIPLOOP INLINE; STAPLE, FIXATION

Catalog Number 110005087

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 05/11/2023

Event Type  malfunction  

Event Description

It was reported that the toggleloc with ziploop inline pulled or cut out the graft while pulling of the thread during the surgery.No adverse event has been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).G2: foreign- india.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product/provided pictures identified sample 1 is missing the blue and white suture and is not assembled. sample 2 also is not assembled and sutures are frayed. as the broken suture thread was not returned, further evaluation was not completed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.The reported event is not confirmed, as the suture line was not returned.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-02220.

• Brand Name: TOGGLELOC WITH ZIPLOOP INLINE
• Type of Device: STAPLE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17807510
• MDR Text Key: 324135312
• Report Number: 0001825034-2023-02219
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00880304567634
• UDI-Public: (01)00880304567634(17)270531(10)0002443231
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Physician
• Type of Report: Initial
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110005087
• Device Lot Number: 0002443231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2022
• 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
• Treatment: 110005087 0002443231.