MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT 1.0MM MINI 2-0 NDLS; FIXATION, FASTENER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: 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 the customer claims tip (fork) of implant bent and then broke during implantation of initial surgery.The physician has used this device for many years without any prior complications.No adverse events have been reported as a result of the malfunction.No additional information in known.

Event Description

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

Manufacturer Narrative

(b)(4) reported event was confirmed per visual examination of the returned product which identified the device tip was fractured.The fracture surface features of the juggerknot mini inserter tip are consistent with those reported in the summary of failure analysis of juggerknot soft anchor inserter tip fractures.The eds semi-quantitative elemental analysis confirmed that the inserter tip material to be consistent with nitinol alloy.Fractography conducted by sem revealed the mode of failure, suspected crack initiation and crack exit sites on the juggerknot inserter tip fractured samples.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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: JGRKNT 1.0MM MINI 2-0 NDLS
• Type of Device: FIXATION, FASTENER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11334972
• MDR Text Key: 233776058
• Report Number: 0001825034-2021-00418
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 00880304520820
• UDI-Public: (01)00880304520820(17)251020(10)835120
• Combination Product (y/n): N
• PMA/PMN Number: K140908
• 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: 04/15/2021

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 Model Number: N/A
• Device Catalogue Number: 912076
• Device Lot Number: 835120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 04/09/2021
• Supplement Dates FDA Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1