MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERSTITCH CURVED IMPLANT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number N/A

Device Problem Material Twisted/Bent (2981)

Patient Problem Tissue Damage (2104)

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the juggerstitch setting instrument bent leading to perforation of the posterior soft tissue; however, the implant is holding.Additionally, injury of the dorsal soft tissue was noted.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon receipt of additional information, it has been determined no serious injury was reported as a result of this malfunction.Additionally, this malfunction has not previously been reported for having caused a serious injury on a same/similar device in the past.The initial report was forwarded in error and should be voided.

Event Description

Upon receipt of additional information, it has been determined no serious injury was reported as a result of this malfunction.Additionally, this malfunction has not previously been reported for having caused a serious injury on a same/similar device in the past.The initial report was forwarded in error and should be voided.

• Brand Name: JUGGERSTITCH CURVED IMPLANT
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9311869
• MDR Text Key: 166201671
• Report Number: 0001825034-2019-05130
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K150424
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110024773
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other