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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US SUTURE MANAGEMENT STERILIZATION CASE; TRAY, SURGICAL, INSTRUMENT
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DEPUY MITEK LLC US SUTURE MANAGEMENT STERILIZATION CASE; TRAY, SURGICAL, INSTRUMENT Back to Search Results
Catalog Number 215402
Device Problems Break (1069); Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2023
Event Type  malfunction  
Event Description
It was reported by a healthcare professional in canada that the suture management sterilization case device was broken and worn down.There was no procedure nor patient involvement reported.No additional information was provided.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, 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.H10 additional narrative: udi: (b)(4).The lot number was unknown.D4, g1, h4: the lot number was unknown; therefore, the expiration date, manufacturing site name and device manufacture date were unknown.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, 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.Device was used for treatment, not diagnosis.If information i obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narative: investigation summary :the complaint device was not returned after multiple attempts for device return, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.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.
 
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Brand Name
SUTURE MANAGEMENT STERILIZATION CASE
Type of Device
TRAY, SURGICAL, INSTRUMENT
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kate karberg
325 paramount drive
raynham, MA 02767
3035526892
MDR Report Key17452028
MDR Text Key320383914
Report Number1221934-2023-02931
Device Sequence Number1
Product Code FSM
UDI-Device Identifier10886705004645
UDI-Public10886705004645
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number215402
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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