MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT SHORT RIGID SZ2 IMP/DRL; FIXATION, FASTENER

Model Number N/A

Device Problem Failure to Fire (2610)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded.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: 0001825034-2021-01904, 0001825034-2021-01906.

Event Description

It was reported that the anchor didn't deploy during surgery.The devices were discarded at the hospital.Attempts have been made and there is no further information at this time.

Event Description

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

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.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 SHORT RIGID SZ2 IMP/DRL
• Type of Device: FIXATION, FASTENER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12083445
• MDR Text Key: 258942935
• Report Number: 0001825034-2021-01907
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00880304568204
• UDI-Public: (01)00880304568204(17)260405(10)373650
• Combination Product (y/n): N
• PMA/PMN Number: K973775
• 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: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• 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: 110005315
• Device Lot Number: 373650
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1