MAUDE Adverse Event Report: DEPUY MITEK LLC US EXPRESSEW III W/O HOOK; SUTURE/NEEDLE PASSER, REUSABLE

Catalog Number	214140
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).Depuy synthes mitek received and evaluated the complaint device.Visual inspection of the device revealed the needle was jammed inside the shaft of the gun and about 3cm of the needle was protruding out of the distal end of the device, confirming this complaint.The distal portion of the needle was broken off and was not returned.No information was provided regarding how or when the needle was broken.However, it appears that the proximal end of the needle is pushed inside the shaft, and the plastic flag which helps load and unload the needle is missing, indicating the needle was pulled out from the distal end of the device which broke the needle.This operation is beyond the design intent of this device.The needle was unable to be removed from the device; therefore the full functionality of the device could not be tested and a root cause for the device failure cannot be conclusively determined.No other device issues or anomalies were noted, and actuation of the jaw lever found the jaws opened and closed as intended.Review of the device history record indicated that this batch of product was processed without incident; therefore there is no internally assignable cause for the reported issue.Review of the depuy synthes mitek complaints system revealed no other complaints of any type for this lot of devices released to distribution.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 to monitor the extent to which this complaint is observed in the field.This report is being filed from the etq 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 the customer's expressew iii without hook failed during a rotator cuff repair surgical procedure due to the needle jamming while in use.The case was completed with another like device.There were no adverse patient consequences or time delays.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).

• Brand Name: EXPRESSEW III W/O HOOK
• Common Device Name: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8270475
• Report Number: 1221934-2018-53148
• Device Sequence Number: 18873853
• Product Code: LXH
• UDI-Device Identifier: 10886982153821
• UDI-Public: 10886982153821
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup
• Report Date (Section B): 01/06/2017

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: 214140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Initial Date Received by Manufacturer: 01/06/2017
• Supplement Date Received by Manufacturer: 01/26/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1