MAUDE Adverse Event Report: DEPUY MITEK LLC US GII INSERTER *EA; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Model Number 212094

Device Problem Break (1069)

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

Event Date 11/08/2020

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The lot number was unknown.To date, the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.

Event Description

It was reported by the sales rep that during a distal bicep procedure on (b)(6) 2020, it was observed that the metal prongs on the inserter gii broke off while the surgeon was malleting in the anchor.According to the report, the prong had to be removed from the anchor because it broke off.Another device was used to complete the procedure with a one minute delay.There were no adverse patient consequences reported.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: according to the information provided, it was reported that during a distal bicep procedure the metal prongs on the inserter gii broke off while the surgeon was malleting in the anchor.The complaint device was discarded by the customer, therefore unavailable for a physical evaluation.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Type of Device: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10927854
• MDR Text Key: 218951227
• Report Number: 1221934-2020-03636
• Device Sequence Number: 1
• Product Code: GEF
• UDI-Device Identifier: 10886705001910
• UDI-Public: 10886705001910
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 212094
• Device Catalogue Number: 212094
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1