MAUDE Adverse Event Report: DEPUY MITEK LLC US EXPRESSSEW III AC GUN; SUTURE/NEEDLE PASSER, REUSABLE

Catalog Number	214157
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Reporter is company sales representative.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported by the sales rep that prior to an unknown case during setting it was found by the scrub tech that the jaw on the customer's expressew iii autocapture flexible suture passer is loose.The procedure was completed with another like device with no patient harm or surgical delay to the case.The sales rep was not present for the case therefore could not provide any further information.The device will be returning for evaluation.This is report 1 of 1 for complaint (b)(4).
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.The complaint device was received and visually inspected.Visual observations revealed the upper jaw was loose due to jaw pin missing.This complaint can be confirmed.Clamping excessive tissue between the jaws combined with repetitive twisting action exerts excess side load on the jaw pin resulting in the jaw pin shearing off from its space.This failure can be attributed to user technique.From the information provided we cannot determine the definitive root cause for the reported failure.A manufacturing record evaluation was performed for the finished device [23433-140507] number, and no non-conformances were identified.At this point, 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 device history a manufacturing record evaluation was performed for the finished device [23433-140507] number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.Additional narrative: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Updated data: device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXPRESSSEW III AC GUN
• Common Device Name: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9193701
• Report Number: 1221934-2019-59006
• Device Sequence Number: 1840484
• Product Code: LXH
• UDI-Device Identifier: 10886705025190
• UDI-Public: 10886705025190
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2019

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: 214157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 10/14/2019; 11/14/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 11/08/2019; 11/15/2019
• Patient Sequence Number: 1