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)
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.This complaint device was received and evaluated.Visual and functional investigation confirms that jaw is not operational.It appears as though the spring that facilitates the actuating of the jaw is broken contributing to this failure.This complaint can be confirmed.A batch record review has been conducted for this lot of devices that were manufactured in 2014 and the results indicate that in this batch of product there were no anomalies or discrepancies in the manufacture of this lot and therefore there is no internally assignable cause for the reported problem.Further, a review into the mitek complaints system revealed no other complaints for the batch number of the 30 devices.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.This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
The instrument was new.The surgeon has used cleverhook alot before.The "mouth" of the instrument broke and could not close properly.Unknown surgery date.With same like product, extended the surgery 10 minutes.

• 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: 7744246
• Report Number: 1221934-2018-53104
• Device Sequence Number: 1365182
• Product Code: NBH
• UDI-Device Identifier: 10886705004225
• UDI-Public: 10886705004225
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2014

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 Catalogue Number: 214641
• Device Lot Number: 14B03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2014
• Initial Report FDA Received Date: 08/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1