MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHRO TISSLIB BLADE DOWN *EA; ORTHOPAEDIC KNIFE

Model Number 214624

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The lot number was unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by the affiliate in (b)(6) that during a shoulder stabilization surgery on an unknown date, it was observed that the arthro tisslib blade down ea device snapped at the handle junction.There was no delay.There were no patient consequences reported.No additional information could be 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 the mitek liberator (blade down) (214624) has snapped at handle junction, a replacement has been requested by the hospital.The complaint device was received and evaluated.Visual observations revealed that the connection of the handle and the shaft were received broken, both pieces were separated.Therefore, this complaint can be confirmed.The laser impressions on the handle and the shaft are faded.The device was worn indicating it was heavily used.Also, shaft was dull to the touch and found with scratches.The possible root cause for the reported failure can be attributed to the age a repeated use of the device causing fair wear and tear; because of this after excessive force applied during a long time can cause to break.However, it cannot be conclusively affirmed 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.

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 the complaint device was not returned after multiple attempts for device return, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.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 KNIFE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10332394
• MDR Text Key: 200613509
• Report Number: 1221934-2020-01942
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705004072
• UDI-Public: 10886705004072
• 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,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 214624
• Device Catalogue Number: 214624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Date Manufacturer Received: 09/11/2020
• Patient Sequence Number: 1