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

Model Number N/A

Device Problems Fracture (1260); Mechanical Jam (2983)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 during a standard trans-tib acl technique, upon trying to implant the xl toggleoc the button became stuck and would not pass through the femur.The button is still in the patient.

Manufacturer Narrative

(b)(4).Surgical technique review and investigation determined femoral tunnel size is not called out and this contributed to the reported event.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to labeling deficiency as the surgical technique did not specify tunnel size when using a toggleloc xl implant.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: 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: 9430463
• MDR Text Key: 169792193
• Report Number: 0001825034-2019-05482
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00880304567641
• UDI-Public: (01)00880304567641
• Combination Product (y/n): N
• PMA/PMN Number: K130033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2022
• Device Model Number: N/A
• Device Catalogue Number: 110005089
• Device Lot Number: 512740
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR