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U.S. Department of Health and Human Services

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

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DEPUY MITEK LLC US EXPRESSEW III W/O HOOK SUTURE/NEEDLE PASSER, REUSABLE Back to Search Results
Catalog Number 214140
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/18/2019
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. (b)(4).
 
Event Description
It was reported by the sales rep via phone that during a rotator cuff repair procedure the customer's expressew iii without hook jaw was loose. The sales rep stated that when the jaw bit down on the tissue, it would not hold. The sales rep stated that the surgeon was not grabbing too much tissue. The case was completed with another like-device with no patient harm or delay. The sales rep was not present and could not provide any additional information. The availability of the device is unknown.
 
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Brand NameEXPRESSEW III W/O HOOK
Type of DeviceSUTURE/NEEDLE PASSER, REUSABLE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key8307552
MDR Text Key135940695
Report Number1221934-2019-56332
Device Sequence Number1
Product Code LHX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number214140
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/06/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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