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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US RESTORE FULLFLUTE REAM 10MM *EA; CANNULATED SURGICAL DRILL

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DEPUY MITEK LLC US RESTORE FULLFLUTE REAM 10MM *EA; CANNULATED SURGICAL DRILL Back to Search Results
Model Number 219340
Device Problem Degraded (1153)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2021
Event Type  malfunction  
Manufacturer Narrative
The lot number was unknown; therefore, the manufacturing site name was unknown.Udi: (b)(4).The lot number was 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.
 
Event Description
It was reported by the sales rep that during an anterior cruciate ligament reconstruction surgery on (b)(6) 2021, it was observed that the restore fullflute ream 10mm device were rounded and not cutting anymore.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay 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 mitek or its employees that the report constitutes an admission that the device, 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: investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Given that lot number was not provided, the 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 to which this complaint is observed in the field.
 
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Type of Device
CANNULATED SURGICAL DRILL
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key12856829
MDR Text Key285931826
Report Number1221934-2021-03405
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10886705005857
UDI-Public10886705005857
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
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/09/2021
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
Device Operator Health Professional
Device Model Number219340
Device Catalogue Number219340
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/09/2021
Initial Date FDA Received11/22/2021
Supplement Dates Manufacturer Received12/06/2021
Supplement Dates FDA Received12/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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