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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. 2-0 SUTURETAPE MENISCUS REPAIR NEEDLES; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
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ARTHREX, INC. 2-0 SUTURETAPE MENISCUS REPAIR NEEDLES; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE Back to Search Results
Model Number 2-0 SUTURETAPE MENISCUS REPAIR NEEDLES
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 04/22/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
 
Event or Problem Description
It was reported that the patient got an infection after he was treated with the devices ar-7900 (lot: 10822462), ar-7910l (lot: 928497924) and ar-7523 (lot: 934399472).This was noticed after the surgery.No further information received.
 
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Brand Name
2-0 SUTURETAPE MENISCUS REPAIR NEEDLES
Common Device Name
SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key11842353
Report Number1220246-2021-03105
Device Sequence Number3747712
Product Code GAT
UDI-Device Identifier00888867298002
UDI-Public00888867298002
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
K122374
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 05/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date11/30/2024
Device Model Number2-0 SUTURETAPE MENISCUS REPAIR NEEDLES
Device Catalogue NumberAR-7523
Device Lot Number934399472
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/26/2021
Initial Report FDA Received Date05/18/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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