MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERKNOT SOFT ANCHORS; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number N/A

Device Problems Bent (1059); Disassembly (1168)

Patient Problem No Information (3190)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign.The event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the anchor was disassembled from the inserter out of box.Surgery was finished with another device after a 15 minute delay to surgery.No further information has been made available at this ttime.

Manufacturer Narrative

Reported event of the anchor being disassembled was unable to be confirmed.However, the device inserter was confirmed to be bent from attempted use.Photos of the device showed heavy presence of biological material on the as well as the sutures.The inserter is shows signs of bending from the attempted implant.The suture and anchor portion of the device have been separated from the inserter.Due to the damage to the product no functional or dimensional analysis is possible.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

It was reported the anchor was noticed to be disassembled from the inserter out of box.Reassembly of the device was attempted, and the device was subsequently used.Subsequently, the inserter bent.Surgery was finished with another device after a 15 minute delay to surgery.No further information has been made available at this time.

• Brand Name: JUGGERKNOT SOFT ANCHORS
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7174746
• MDR Text Key: 96728409
• Report Number: 0001825034-2017-11485
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK110879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2022
• Device Model Number: N/A
• Device Catalogue Number: 912082
• Device Lot Number: 924640
• Other Device ID Number: (01) 0088304 523418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1