MAUDE Adverse Event Report: BIOMET ORTHOPEDICS TOGGLELOC XL WITH ZIPLOOP; FASTENER, FIXATION

Model Number N/A

Device Problems Device Misassembled During Manufacturing /Shipping (2912); Misassembly by Users (3133)

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

Event Date 09/15/2014

Event Type  malfunction  

Event Description

It was reported that during an anterior cruciate ligament reconstruction procedure on (b)(6) 2014, the suture thread was assembled in the back hole instead of in the front hole.In order to complete the procedure, the implant had to be reassembled.A delay of less than thirty minutes occurred.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under warnings it states, "the surgeon must be thoroughly knowledgeable not only in the medical and surgical aspects of the implant, but also must be aware of the mechanical and metallurgical aspects of the surgical implants.".

Manufacturer Narrative

Reported event was confirmed by review of photographs.Photographs show that the suture is assembled in the incorrect hole.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action(s) is/are required.Investigation results concluded that the reported event was due to manufacturing/training related as the product was misassembled.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.

• Brand Name: TOGGLELOC XL WITH ZIPLOOP
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4178873
• MDR Text Key: 5096831
• Report Number: 0001825034-2014-08125
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PK130033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 110005089
• Device Lot Number: 545270
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1