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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHRO CLEVERHOOK-LEFT *EA; SKIN/TISSUE HOOK
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DEPUY MITEK LLC US ARTHRO CLEVERHOOK-LEFT *EA; SKIN/TISSUE HOOK Back to Search Results
Model Number 214641
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/08/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported by the sales rep that during a rotator cuff repair, it was observed that the tip of the clever hook left was bent and dull.Another device was used to complete the procedure.No patient consequences or 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: h6: method codes: a manufacturing record evaluation was performed for the finished device [18r01] number, and no non-conformances were identified.
 
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.Investigation summary according to the information provided, it was reported by the sales rep via phone that during a rotator cuff repair the tip of the clever hook - left is bent and dull.The complaint device was received and evaluated.Visual observations confirm that the tip of the upper jaw it was bent slightly.In addition, the device presented marks of wear in the shaft and in the jaws.Besides, the laser lines etched on the device were found faded.The complaint can be confirmed.The possible root cause for the reported failure can be associated for the excessive use of the device or or being mishandled/ dropped.However, it cannot be conclusively affirmed.A manufacturing record evaluation was performed for the finished device [18r01] 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.
 
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Type of Device
SKIN/TISSUE HOOK
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key10343412
MDR Text Key200986369
Report Number1221934-2020-01952
Device Sequence Number1
Product Code NBH
UDI-Device Identifier10886705004225
UDI-Public10886705004225
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
Report Date 07/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number214641
Device Catalogue Number214641
Device Lot Number18R01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2020
Date Manufacturer Received08/27/2020
Patient Sequence Number1
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