MAUDE Adverse Event Report: DEPUY MITEK LLC US PENETRATING GRASPER - 45 DEGREE LEFT; 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	05/20/2014
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 shaft on the device is slightly bent considerably indicating excessive mechanical force being applied on the device during use.The jaws do not operate as intended, thus confirming this complaint.This type of failure can be attributed to heavy use and exerting too much pressure in operating the device which is consistent with the description provided.A batch record review has been conducted and our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.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.(b)(4).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
It was reported by the sales rep that during a shoulder repair, it was observed that the spring broke on his penetrating grasper when the surgeon was using the device.The sales rep confirmed nothing fell inside the patient.The surgeon completed the procedure with another like device with no patient consequences or delay.The sales rep could not provide the lot number but reported the device is over 2 years old and has seen heavy use.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: PENETRATING GRASPER - 45 DEGREE LEFT
• Common Device Name: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7812473
• Report Number: 1221934-2018-54541
• Device Sequence Number: 216625
• Product Code: NBH
• UDI-Device Identifier: 10886705003853
• UDI-Public: 10886705003853
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 05/20/2014

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: 13D03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2014
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2014
• Initial Report FDA Received Date: 08/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1