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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHROCARE CORP. SMARTSTITCH PP CONNECTOR; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
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ARTHROCARE CORP. SMARTSTITCH PP CONNECTOR; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE Back to Search Results
Model Number OM-8010
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/16/2017
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during shoulder procedure, that perfect passer connector top jaw fell off.When the device was pulled out of the shoulder, the top jaw was missing.Missing piece was located on the floor.The procedure was completed without significant delay using a back-up device.No patient injury or other complications were reported.
 
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Brand Name
SMARTSTITCH PP CONNECTOR
Common Device Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Manufacturer (Section D)
ARTHROCARE CORP.
7000 w. william cannon
austin TX 78735
MDR Report Key9966168
Report Number3006524618-2020-00208
Device Sequence Number14371554
Product Code GAT
UDI-Device Identifier00817470006971
UDI-Public00817470006971
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K123268
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 04/15/2020
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
Operator of Device Health Professional
Device Expiration Date01/31/2020
Device Model NumberOM-8010
Device Catalogue NumberOM-8010
Device Lot Number1182577
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/30/2017
Initial Report FDA Received Date04/16/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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