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	05/28/2015
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.The complaint device was received and evaluated.Visual inspection reveals the device is worn.The trigger mechanism is broken and the device will not function.These can be attributed to the age of the device and the heavy usage.This complaint can be confirmed.A batch review was not conducted as the batch number is unknown.However, 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).Depuy mitek has been informed that the lot number is not available.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 prior to an acl procedure the jaw on their suture grasper is broken and their femoral aimer 8 mm offset is bent.The surgeon completed the procedure with another like device with no patient consequences or delays.The sales rep could not provide a lot number for the devices.The device will be returning for evaluation.

• Common Device Name: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7753722
• Report Number: 1221934-2018-53538
• Device Sequence Number: 1567208
• Product Code: HCF
• UDI-Device Identifier: 10886705003822
• UDI-Public: 10886705003822
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 05/28/2015

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2015
• Initial Report FDA Received Date: 08/06/2018
• Patient Sequence Number: 1