MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TOGGLELOC WITH ZIPLOOP INLINE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	N/A
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up/final report will be submitted.
Event or Problem Description
It was reported the anchor failed to deploy during use.No further information has been made available at the time of this reporting.
Additional Manufacturer Narrative
Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.
Event or Problem Description
Upon reassessment of the reported event it was determined that the event is no longer considered as reportable.The initial report was submitted in error and needs to be voided.

• Brand Name: TOGGLELOC WITH ZIPLOOP INLINE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9378304
• Report Number: 0001825034-2019-05266
• Device Sequence Number: 11302384
• Product Code: MBI
• UDI-Device Identifier: 00880304567634
• UDI-Public: (01)00880304567634
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• 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): 03/31/2020

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: 05/08/2024
• Device Model Number: N/A
• Device Catalogue Number: 110005087
• Device Lot Number: 978690
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 04/01/2020
• 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