MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHRO GRASPER PEN 45 RIGHT *EA; SUTURE/NEEDLE PASSER, REUSABLE

Catalog Number	214603
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2018
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) incomplete.The lot number is not currently available.Investigation summary: the complaint device is not available for physical evaluation, hence, the complaint cannot be confirmed.No lot numbers were supplied which precludes conducting a dhr review.Given the information provided we cannot discern a definitive root cause for the reported failure.At this point, 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 sales rep that during rotator cuff repair surgical procedure, it was observed that the pin in handle on the arthro grasper pen 45 right *ea was missing.According to the reporter, the device would not open and close.It was further reported that the surgeon could not pass suture with product and used expressew instead.It was not reported if there was a delay in the surgical procedure.It was not reported if 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: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9036990
• Report Number: 1221934-2019-58305
• Device Sequence Number: 2411136
• Product Code: NBH
• UDI-Device Identifier: 10886705003860
• UDI-Public: 10886705003860
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2018

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: 214603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2018
• 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