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

Model Number 214641

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device was used for treatment, not diagnosis.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 an unknown procedure the expressew iii suture passer w/o hook and the clever hook - left were broken.The jaws of the devices are not opening and closing.The complaint device was received and evaluated.Visual inspection was performed and not significant damage was observed functional testing revealed difficulties operating the device.There was resistance as trying to close and open the jaws, the jaw only move as manual mode, the lower jaw was loose and it was not allow to hold, therefore the complaint was confirmed.The possible root cause for the reported failure can be attributed to use normal wear and tear of the device as the device is reusable, however; this cannot be conclusive determined.  a manufacturing record evaluation was performed for the finished device [09g3] number, and no non-conformances were identified.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.(b)(4).

Event Description

It was reported by the sales rep via phone that during an unknown procedure the expressew iii suture passer w/o hook and the clever hook - left were broken.The jaws of the devices are not opening and closing.Another devices were used to complete the procedure.No patient consequences or surgical delay reported.These products will be returned for analysis.

• Type of Device: SKIN/TISSUE HOOK
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9739693
• MDR Text Key: 200394164
• Report Number: 1221934-2020-00635
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705004225
• UDI-Public: 10886705004225
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 214641
• Device Catalogue Number: 214641
• Device Lot Number: 09G3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Date Manufacturer Received: 02/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2009
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1