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

Catalog Number	214140
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2018
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.(b)(4).Associated medwatch [mr# 1221934-2018-50587].
Event or Problem Description
It was reported by the sales rep via phone that during a rotator cuff procedure the needle got jammed inside of the expressew iii without hook and they were unable to remove it from the device.The procedure was completed with another like device with no harm to the patient or delays to the case.The device will be returning for evaluation.
Additional Manufacturer Narrative
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.Correction: udi#: the unique identifier( udi) was reported as (b)(4) in the initial report and has been corrected as (b)(4).Therefore, udi: (b)(4).Additional information: investigation summary: the complaint device is not being returned, multiples attempts for product return were made with no response, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.  a device history record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.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.

• 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: 7492216
• Report Number: 1221934-2018-50586
• Device Sequence Number: 16513131
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2018

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
• Device Lot Number: 33620-150824
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1