MAUDE Adverse Event Report: DEPUY MITEK LLC US CLEVER HOOK LEFT; SKIN/TISSUE HOOK

Catalog Number	214641
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/23/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the complaint device was received and inspected.Visual observation confirms that the distal sharp tip of the upper jaw is slightly distorted consistent with the device accidentally hitting bone at an off angle or another object.This failure can be attributed to mishandling of the device.A batch record review has been conducted and the results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other similar complaints for this lot of devices that were released to distribution.At this point in time, no corrective action is required and no further action is warranted.However, depuy 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.Udi: (b)(4).
Event or Problem Description
It was reported by the affiliate in (b)(6) that the tip of the clever hook left device snapped off.The procedure was completed with same like product.It was not reported if there were any delays in the surgical procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: CLEVER HOOK LEFT
• Common Device Name: SKIN/TISSUE HOOK
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7804956
• Report Number: 1221934-2018-52681
• Device Sequence Number: 1510669
• Product Code: NBH
• UDI-Device Identifier: 10886705004225
• UDI-Public: 10886705004225
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2014

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 214641
• Device Lot Number: 13C02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2014
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2014
• Initial Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1