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

Catalog Number	214642
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2018
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) investigation summary: the complaint device was received and inspected.The complaint can be confirmed.It was observed that when the trigger of the device was pulled, the grasper would not actuate in/out.It appears that the shaft between the trigger and the grasper has become loose.It is possible that the sheer pin on this device has broken and does not work.This device was designed in a way that the sheer pin was intended to fail before the device fails in any other way and the complaint device has adhered to this failure mode.A review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices with the product code that were released to distribution.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective and preventative 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) that during a rotator cuff repair, it was observed that there was a snap sound that was heard when the surgeon was pushing the arthro sixter-right *ea device into the incision.According to the report, the event occurred when the surgeon picked up the device and attempted to use it on the patient but due to the swelling of the patient it was difficult to get the device in the incision.It was further reported that when the surgeon pulled the sixter out, he realized that he must have broken the mechanism that opens and closes the jaws of the device.It was reported that another tray was opened to use the clever hooks instead for the rest of the case.The surgery was delayed only about one minute while we grabbed the tray to open the clever hooks.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: 9117649
• Report Number: 1221934-2019-58501
• Device Sequence Number: 16606488
• Product Code: NBH
• UDI-Device Identifier: 10886705004232
• UDI-Public: 10886705004232
• 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): 06/29/2018

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: 214642
• Device Lot Number: 13N02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1