MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRLOC B2B RD SS SLD DRL KIT; FASTENER, FIXATION

Model Number	N/A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and 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 that a biomet juggerloc bone to bone was inserted according to the prescribed surgical technique.The green inserter handle was removed and the surgeon began pulling on the tight rope loop, moving the button towards the plate.As it neared the end of the suture loop it stopped moving and would not continue moving to gain compression of the syndysmosis gap.The surgeon tried many times to get it moving, but could not, leaving about three (3) mm gap between the button and the plate.The surgeon cut the device out and replaced with the biomet ziptight.
Additional Manufacturer Narrative
(b)(4).Upon receipt of additional information it has been determined that this is not a reportable issue as the malfunction did not cause any serious injury in the past.The initial report was submitted in error and needs to be voided.
Event or Problem Description
Upon receipt of additional information it has been determined that this is not a reportable issue as the malfunction did not cause any serious injury in the past.The initial report was submitted in error and needs to be voided.

• Brand Name: JGRLOC B2B RD SS SLD DRL KIT
• Common Device Name: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9538019
• Report Number: 0001825034-2019-05813
• Device Sequence Number: 2341372
• Product Code: HTN
• UDI-Device Identifier: 00880304680319
• UDI-Public: (01)00880304680319
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K141219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/08/2024
• Device Model Number: N/A
• Device Catalogue Number: 110007337
• Device Lot Number: 019950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 06/04/2020
• 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
• Patient Age: 27 YR