MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RC ARTHRORIVET; STAPLE, FIXATION

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Information (3190)

Event Date 09/11/2009

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.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 a l rotator cuff repair, the surgeon attempted to implant the device, and it did not deploy due to incorrect angle.Surgeon was able to complete the procedure with 2 devices of the same lot.Attempts have been made and no further information as been provided.

Event Description

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

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of op notes.Op notes indicated two arthrorivet devices were deployed.A third was attempted but the angle was wrong and it did not take.It was decided two rivets would be sufficient reinforced with the ethibond repair.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.

• Brand Name: RC ARTHRORIVET
• Type of Device: STAPLE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8499077
• MDR Text Key: 141445619
• Report Number: 0001825034-2019-01628
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• PMA/PMN Number: K951658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2013
• Device Model Number: N/A
• Device Catalogue Number: 905802
• Device Lot Number: 704640
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2019
• Initial Date FDA Received: 04/10/2019
• Supplement Dates Manufacturer Received: 06/06/2019
• Supplement Dates FDA Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 51