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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL EXPRESSEW III AC+ GUN; SUTURE/NEEDLE PASSER, REUSABLE
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MEDOS INTERNATIONAL SàRL EXPRESSEW III AC+ GUN; SUTURE/NEEDLE PASSER, REUSABLE Back to Search Results
Model Number 288233
Device Problems Failure to Advance (2524); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/21/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).
 
Event Description
It was reported by the sales rep via phone that during a rotator cuff repair the expressew iii autocapture + suture passer was bent as it was not releasing the suture properly.Another device was used to complete the procedure.No patient consequences or surgical delay reported.
 
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 the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H10 additional narrative: additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported by the sales rep that he does not know how the device got bent.He confirmed that it was during the surgery that the device was observed to be not working properly.
 
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 the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H10 additional narrative: additional information: investigation summary
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> according to the information provided, it was reported that the expressew was bent and did not release the suture properly.The complaint device is not being returned, multiples attempts for product return were made with no response, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device [1049141-181012] number, and no non-conformances were identified.At this point in 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.Device history lot
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> a manufacturing record evaluation was performed for the finished device [1049141-181012] number, and no non-conformances were identified.
 
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 the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H10 additional narrative: correction: the device was returned and the device evaluation was updated to reflect this: investigation summary: according to the information provided, it was reported that the expressew was bent and did not release the suture properly.The device was received and visually inspected.Visual observations reveal the device is slightly worn, used but in expected condition.Besides, it was not possible identified the bent part of the expressew.To test its functionality, a needle was loaded into the device and was tested on a sample rubber strip.It was observed that the when the trigger was actuated the needle it was difficult to deploy it, in consequence the suture not release properly.During the test, the needle constantly was very hard to deploy causing the device to jam.The trigger had to be manually pushed back to retract the needle to its original position.This complaint can be confirmed.The possible cause can be attribute to fair wear and tear of the device also a lack of maintenance would lead to tissue or bio-debris build up inside the expressew shaft causing wear of internal components leading to rough deployment issues.However, it cannot be conclusively affirmed.      a manufacturing record evaluation was performed for the finished device [1049141-181012] number, and no non-conformances were identified.At this point in 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.Udi: (b)(4).
 
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Brand Name
EXPRESSEW III AC+ GUN
Type of Device
SUTURE/NEEDLE PASSER, REUSABLE
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ  02400
MDR Report Key9650414
MDR Text Key191541611
Report Number1221934-2020-00387
Device Sequence Number1
Product Code LXH
UDI-Device Identifier10886705027101
UDI-Public10886705027101
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup,Followup,Followup
Report Date 01/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number288233
Device Catalogue Number288233
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2020
Date Manufacturer Received03/20/2020
Patient Sequence Number1
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