MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TOGGLELOC XL WITH ZIPLOOP; FASTENER, FIXATION

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Patient not revised.

Event Description

It has been reported that patient underwent total arm arthroplasty.However, a wrong sized implant was implanted which resulted in pain, disfigurement, and other unknown problems.No additional patient consequences were reported.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of instructions for use (ifu), which states that the toggleloc xl device is used for fixation of tendons and ligaments in cases of unanticipated intraoperative complications such as cortical breaching during orthopedic reconstruction procedures, such as anterior cruciate (acl) or posterior cruciate (pcl) reconstruction.Device history record was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to off label use.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.Product not returned.

• Brand Name: TOGGLELOC XL WITH ZIPLOOP
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8559621
• MDR Text Key: 143377440
• Report Number: 0001825034-2019-01901
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• PMA/PMN Number: K173278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 110005089
• Device Lot Number: 225710
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/28/2019
• Supplement Dates Manufacturer Received: 06/26/2019
• Supplement Dates FDA Received: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other