MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT 1.4MM CRVD KIT W SLV; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 02/25/2019

Event Type  malfunction  

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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2019 -01373.

Event Description

It has been reported that the obturator were already fractured while the packages were opened during inspection.There was no patient involvement.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).Concomitant medical products : catalog #: 912140c, jgrknt 1.4mm crvd kit w slv, lot # 648640 qty: 8, catalog #: 912140c, jgrknt 1.4mm crvd kit w slv, lot # 648630 qty: 7.Reported event was considered confirmed as the returned items were fractured.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was considered to be a manufacturing deficiency and related to cleaning during manufacture.The complaint is being addressed through the capa process.A summary of the investigation has been sent to the complainant.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03822, 0001825034 - 2019 - 03833, 0001825034 - 2019 - 03834, 0001825034-2019-03835, 0001825034 - 2019 - 03836, 0001825034 - 2019 - 03837, 0001825034 - 2019 - 03838, 0001825034-2019-01372, 0001825034-2019-01373, 0001825034-2019-03840, 0001825034-2019-03841, 0001825034-2019-03844, 0001825034-2019-03845.

Event Description

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

• Brand Name: JGRKNT 1.4MM CRVD KIT W SLV
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8449181
• MDR Text Key: 139743234
• Report Number: 0001825034-2019-01372
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K150768
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2022
• Device Model Number: N/A
• Device Catalogue Number: 912140C
• Device Lot Number: 648640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1