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

Model Number N/A

Device Problems Device Operates Differently Than Expected (2913); Difficult to Advance (2920)

Patient Problem No Code Available (3191)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that 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.

Event Description

It was reported that the suture bundled up behind the button as the surgeon was trying to work the button down to the fibular plate.The surgeon had to cut the implant out and use an alternative device from another company.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed through photographic visual evidence of the reported device.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Discarded, not returned to manufacturer.

• Brand Name: JGRLOC B2B RD SS SLD DRL KIT
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7347026
• MDR Text Key: 102710263
• Report Number: 0001825034-2018-01978
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• PMA/PMN Number: PK141219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2021
• Device Model Number: N/A
• Device Catalogue Number: 110007337
• Device Lot Number: 672790
• Other Device ID Number: (01) 0880304680319
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 23 YR