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

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2019

Event Type  Injury  

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.

Event Description

It was reported that during procedure, the implant did not bunch as it should have, and was pulled out.This had no impact on the patient as a replacement product was used in its place.No more information available.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was not confirmed, as the inserter component was returned, but not the malfunctioning anchor/suture construct.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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 Description

No further event information available at the time of this report.

• Brand Name: JGRLOC B2B RD SS SLD DRL KIT
• Type of Device: FASTNER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8900867
• MDR Text Key: 195614597
• Report Number: 0001825034-2019-03468
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• PMA/PMN Number: K141219
• 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: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2024
• Device Model Number: N/A
• Device Catalogue Number: 110007337
• Device Lot Number: 660700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1