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

Catalog Number	214602
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2013
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: the complaint device was received and inspected.The handle seems loose as though it is broken/missing a spring inside that provides tension.The jaws do not operate as intended, thus confirming this complaint.The handle is discolored and the device is extremely worn.This type of failure can be attributed to normal field wear.From the lot number provided, this device is 11 years old and therefore possibly seen very heavy use, further, a review into the depuy mitek complaints system revealed no other complaints for this lot of 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.Dhr: a review of the device history record indicated that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.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 sales representative reported that during a shoulder repair that the customer's penetrating grasper 45 degree left, broke when penetrating the rotator cuff.The sales representative confirmed nothing broke off or fell inside the patient.The surgeon completed the procedure with another device with no patient consequences or delay.The sales representative reported that the device has seen heavy use.

• Common Device Name: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8024870
• Report Number: 1221934-2018-52497
• Device Sequence Number: 13751748
• Product Code: NBH
• UDI-Device Identifier: 10886705003853
• UDI-Public: 10886705003853
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/02/2013

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: 214602
• Device Lot Number: 2H2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2013
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2013
• Initial Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1