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

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/20/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: TOGGLELOC XL WITH ZIPLOOP
• Common Device Name: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9430463
• Report Number: 0001825034-2019-05482
• Device Sequence Number: 18966251
• Product Code: JDR
• UDI-Device Identifier: 00880304567641
• UDI-Public: (01)00880304567641
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K130033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

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?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 05/27/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR