MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHRO CLEVERHOOK-RIGHT *EA; SKIN/TISSUE HOOK

Model Number 214640

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2020

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.Additional narrative: udi: (b)(4).Investigation summary: according to the information, it was reported that blind device received in decon site on 03/20/2020 with no complaint information attached and could not be associated with an existing complaint.The device was received and evaluated.Visual observation reveals that it appears to be old, indicate possible heavy use.Also, the laser lines were faded.Functional testing indicated difficulties operating the device, there was resistance as trying to close and open the jaws.The lower jaw was loose contributing to the holding failure.This failure can be attributed to normal field wear.It was determined from past investigations of similar failure modes that this product in general is susceptible to the autoclave process negatively affecting the laser lines.Also, the loose failure is attributed to rough handling or possibly coming into contact with another hard object.However, it cannot be conclusively affirmed.A manufacturing record evaluation was performed for the finished device lot number: (b)(4), and no non-conformances were identified.At this time, no corrective action is required, and no further action is warranted, as the device is fully functional.However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.Device history lot: a manufacturing record evaluation was performed for the finished device lot number: (b)(4), and no non-conformances were identified.

Event Description

It was reported that arthro cleverhook-right *ea had an unspecified malfunction.During in-house engineering evaluation, it was determined that the lower jaw on the device was loose.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.There were no reports of any injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Type of Device: SKIN/TISSUE HOOK
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 10206441
• MDR Text Key: 196842614
• Report Number: 1221934-2020-01671
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705004218
• UDI-Public: 10886705004218
• 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,other
• Type of Report: Initial
• Report Date: 06/26/2020

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: 214640
• Device Catalogue Number: 214640
• Device Lot Number: 18N01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 06/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2018
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1