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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHROCARE CORP. T-PUNCH ASSEMBLY; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
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ARTHROCARE CORP. T-PUNCH ASSEMBLY; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE Back to Search Results
Catalog Number OM9020
Device Problem Difficult to Insert (1316)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/07/2020
Event Type  malfunction  
Event Description
It was reported that, during surgery, the t-bar handle of the "3.2mm magnum punch assembly" came away from the punch when the surgeon removed it from the trocar.Although the surgery was not delayed, it is unknown if a back-up device was available to complete the procedure.No patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
Event Description
It was reported that, during a rotator cuff repair surgery, the t-bar handle of the "3.2mm magnum punch assembly" came apart from the punch when the surgeon removed it from the trocar inside the patient.All the pieces were successfully removed from the patient.Although the surgery was completed with no delay, it is unknown if a back-up device was available to complete the procedure.No further complications were reported.
 
Manufacturer Narrative
It was reported that, during a rotator cuff repair surgery, the t-bar handle of the "3.2mm magnum punch assembly" came apart from the punch when the surgeon removed it from the trocar inside the patient.All the pieces were successfully removed from the patient.Although the surgery was completed with no delay, it is unknown if a back-up device was available to complete the procedure.No further complications were reported.The reported device, used in treatment, was returned for evaluation.There was a relationship found between the reported incident and the returned device.A review of the device history records for the reported lot number showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found: -as with any surgical instrument, careful attention should be made to assure that excessive force is not placed on this instrument.Excessive force can result in failure.-always actuate the instrument prior to clinical use to verify the device is functioning properly.Visual inspection shows a device with a detached handle/loose rod.The weld on the rod did not withstand the strain.No manufacturing anomalies can be identified on the returned device.It is a single use device and could not be functional tested.The complaint was confirmed.Factors that could have contributed to the reported event include: (1) excessive force.No containment or corrective actions are recommended at this time.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
 
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Brand Name
T-PUNCH ASSEMBLY
Type of Device
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Manufacturer (Section D)
ARTHROCARE CORP.
7000 w. william cannon
austin TX 78735
MDR Report Key10336319
MDR Text Key200761736
Report Number3006524618-2020-00545
Device Sequence Number1
Product Code MDM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 10/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberOM9020
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received10/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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