MAUDE Adverse Event Report: DEPUY MITEK LLC US EXPRESSEW II FLEXIBLE SUTURE PASSER -NS; SUTURE/NEEDLE PASSER, REUSABLE

Catalog Number 214004

Device Problems Bent (1059); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary
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> the complaint device was received and evaluated.Visual observations revealed that the left side of the upper jaw hook was bent inwards.This type of failure could be attributed to blunt force impact; potential root causes include the device hitting bone during a procedure or the device being mishandled.Via functional test, when the trigger was actuated, the jaws did not function properly.The jaws did close successfully, however the jaws couldn¿t open unless by force, pulling on the jaw lever.This complaint is confirmed.A test needle was loaded in the needle tray and the needle lever was actuated.The needle extract and returned successfully.A possible root cause for the jaws not opening as intended cannot be determined.The dhr review indicated that this batch of devices was processed without incident therefore, there is no evidence of manufacturing anomalies on the records reviewed.Furthermore, a related complaint search in depuy synthes mitek complaints system revealed no complaints of any type for this lot of devices that was released to distribution.And at this time 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.(b)(4).Associated medwatch [mr#: 1221934-2018-52262].

Event Description

The previous sales rep for this account left the company and when the current sales rep went to the account, he was handed a box of 8 different devices with no procedure dates, no failures for each device, or any information regarding procedures.The sales rep when observing the devices believes that the following failures are: expressew ii flexible suture passer the jaw is not opening or closing expressew iii without hook the jaw is not opening or closing ratchet handle with jacob's chuck is no longer ratcheting, device is sticking arthro suture scissor the distal tip appears to be bent two cord cutters one is not sliding properly and the other the inside distal tip appears to be broken off anteromedial femoral aimer 7.5mm where the handle and driver meet is loose modular driver 23mm is bent at the distal tip the sales rep stated that the customer did not report any patient harms to him.The devices will be returning for evaluation.

• Brand Name: EXPRESSEW II FLEXIBLE SUTURE PASSER -NS
• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 7629678
• MDR Text Key: 112046125
• Report Number: 1221934-2018-52261
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 214004
• Device Lot Number: 11849CZ-090519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1