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

Catalog Number	214640
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2015
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: this complaint device was received and evaluated.Visual and functional investigation revealed corrosion, scratches, and that the actuator was broken near the distal tip of the device, contributing to the jaw failure.This complaint can be confirmed.The device is 10 years old and has seen considerable use in the field which is consistent with its appearance.This failure can be attributed to fair wear and tear.A batch review request to the supplier determined this device is more than 2 years old and a batch review could not be performed.Further, a review into the mitek complaints system revealed no other complaints from this lot of devices that were released for distribution in 2005.At this point in time, 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.This report is being filed from the (b)(4) as required under mitek¿s corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
The sales representative reported that prior to a shoulder procedure the shaft component on the customer's clever hook right that opens and closes the jaw was cracked.The surgeon completed the procedure with another like device with no patient consequences or delays.The sales representative was not present for the case and could not provide any further information.The device will be returning for evaluation.

• Brand Name: CLEVER HOOK RIGHT
• Common Device Name: SKIN/TISSUE HOOK
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8008699
• Report Number: 1221934-2018-54451
• Device Sequence Number: 169451
• Product Code: NBH
• UDI-Device Identifier: 10886705004218
• UDI-Public: 10886705004218
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2015

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: 214640
• Device Lot Number: 5L1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2015
• Initial Report FDA Received Date: 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1