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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US EXPRESSEW III W/HOOK; SUTURE/NEEDLE PASSER, REUSABLE
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DEPUY MITEK LLC US EXPRESSEW III W/HOOK; SUTURE/NEEDLE PASSER, REUSABLE Back to Search Results
Catalog Number 214124
Device Problems Bent (1059); Loose or Intermittent Connection (1371); Material Twisted/Bent (2981)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 05/25/2018
Event Type  malfunction  
Manufacturer Narrative
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 procedure the jaw on the customer's expressew with hook appears to be bent or loose and no longer able to grip tissue.The procedure was completed with another like device with no harm to the patient but there was a three minute delay to grab another gun and load the device.The sales rep was not present for the case therefore could not provide any further information.The device will be returning for evaluation.
 
Event Description
It was reported by the sales rep via phone that during a rotator cuff repair procedure the jaw on the customer's expressew with hook appears to be bent or loose and no longer able to grip tissue.The procedure was completed with another like device with no harm to the patient but there was a three minute delay to grab another gun and load the device.The sales rep was not present for the case therefore could not provide any further information.The device will be returning for evaluation.
 
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).
 
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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary
=
> the complaint device was received and inspected.The complaint cannot be confirmed.A visual observation was performed to inspect the device for any gross visual defects.The jaws of the device were clamped downward, and were found to operate as intended.The jaws did not appear to be bent, or loose in any way.A device history record (dhr) 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.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.Udi: (b)(4).
 
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Brand Name
EXPRESSEW III W/HOOK
Type of Device
SUTURE/NEEDLE PASSER, REUSABLE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key7611125
MDR Text Key111480310
Report Number1221934-2018-52012
Device Sequence Number1
Product Code LXH
UDI-Device Identifier10886705003655
UDI-Public10886705003655
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,health
Type of Report Initial,Followup,Followup
Report Date 05/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number214124
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2018
Date Manufacturer Received10/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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