MAUDE Adverse Event Report: DEPUY MITEK LLC US LATARJET CCOID THREAD; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Model Number 285255

Device Problems Material Deformation (2976); Illegible Information (4050)

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

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).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 affiliate in (b)(6) that the latarjet ccoid thread device was stripped.There was no procedure nor patient involvement 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: background: the mdr department is complaining about the instruments in this set, saying the bolts that hold the driver shafts in the handles can come loose or hold debris under them.Investigation summary: the latarjet ccoid thread (part #: 285255, lot #: 13n01) was received and evaluated at us cq.Upon visual inspection, the distal tip of the device was found to be stripped.Also, the etch was fading and difficult to read.Hence, the reported condition can be confirmed.The possible root cause for the fading etch could be attributed to fair wear and tear from the repeated use and sterilization cycles.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent to which this complaint is observed in the field a manufacturing record evaluation was performed for the finished device lot number (13n01), and no non-conformances related to the reported complaint condition were identified.

• Brand Name: LATARJET CCOID THREAD
• Type of Device: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12158677
• MDR Text Key: 261271431
• Report Number: 1221934-2021-02179
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705017973
• UDI-Public: 10886705017973
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

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: 285255
• Device Catalogue Number: 285255
• Device Lot Number: 13N01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/13/2021
• Supplement Dates Manufacturer Received: 06/25/2021
• Supplement Dates FDA Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1