MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TOGGLELOC XL W/ZIPLOOP INLINE; PROSTHESIS, SPORTSMED

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign: event occurred in (b)(6).The product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.
Event or Problem Description
It was reported that the toggleloc xl fractured during a procedure.The event took place at the end of the surgery, after obtaining the desired tension of the acl graft for the silva technique in the tibial tunnel.Attempts have been made and additional information on the reported event is unavailable.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided picture identified a piece of the suture broken off.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.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 or Problem Description
No further event information is available at the time of this report.

• Brand Name: TOGGLELOC XL W/ZIPLOOP INLINE
• Common Device Name: PROSTHESIS, SPORTSMED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9677653
• Report Number: 0001825034-2020-00357
• Device Sequence Number: 2371534
• Product Code: MBI
• UDI-Device Identifier: 00880304567658
• UDI-Public: (01)00880304567658
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K130033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2024
• Device Model Number: N/A
• Device Catalogue Number: 110005090
• Device Lot Number: 121580
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1