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

Catalog Number	214640
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Udi: (b)(4).The lot number is not currently available.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Investigation summary: as no further information is forthcoming, this complaint device has been considered discarded.Therefore is unavailable for a physical evaluation and cannot be confirmed at this time.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.The reported failure can potentially be attributed to excessive clamping of tissue which contributes to the jaw failure.However, the information provided was not sufficient to discern a definitive root cause.If any additional information is obtained, this complaint will be re-opened to capture that information.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.This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the affiliate in (b)(6) via e-mail that during shoulder arthroscopy rotator cuff repair, instruments were found to be broken - jaw of instrument not opening or closing.Initially working well, but after several passing of suture through tendon that was difficult, jaw of instrument would not open or close.Alternate device sourced with a one minute delay to procedure.No ae to patient.There was a delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of 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.

• Common Device Name: SKIN/TISSUE HOOK
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9042762
• Report Number: 1221934-2019-58321
• Device Sequence Number: 2155919
• Product Code: NBH
• UDI-Device Identifier: 10886705004218
• UDI-Public: 10886705004218
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• 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): 04/26/2018

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1