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

Catalog Number	214575
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2014
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: this complaint is being closed since after multiple email attempts to retrieve the product, the product still hasn't been returned for evaluation.If and when the device in question is received, this file will be reopened and its contents made to reflect the results of the evaluation.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.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) - incomplete.The lot number is currently unavailable.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 damaged device.The handle and the shaft are broken.No consequences to the patient - another like device was used.The following information was received from our affiliate on 8-5-14; there was nothing that broke off of the device and fell into the patient, and there is no information as to how old the device is.

• Common Device Name: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7721435
• Report Number: 1221934-2018-52287
• Device Sequence Number: 19214444
• Product Code: HCF
• UDI-Device Identifier: 10886705003822
• UDI-Public: 10886705003822
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2014

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: 214575
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2014
• Initial Report FDA Received Date: 07/25/2018
• Patient Sequence Number: 1