MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	SL-613
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, prior to orthopedic surgery, upon opening the package, there was no needle, only the thread.The product was not used.A new device was used to complete the case.
Additional Manufacturer Narrative
Additional information: d10, g4, h3, h6 h3 evaluation summary: post market vigilance (pmv) led an evaluation of one device.A visual inspection of the returned product noted one suture and one needle.The suture was wound in the retainer, but the needle was not parked in the foam of the retainer.Microscopic inspection of the foam noted that no parking marks were present in the foam.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.However, a manufacturing fault was identified during product analysis.Additionally, the investigation detected an unreported condition of needle not parked in the foam of the retainer that has no relationship to the reported condition.The root cause was attributed to poor needle placement at module 30 of semi- attaching retaining machine (sarm) #1.This lot consisted of the c-23 needle type and they are smaller in diameter and length compared to other needles processed on the sarm machines.There is less needle to interact and create friction with the cover and foam that holds the needles in place within the universal retainer.The combination of small needle length, wire diameter, as well as needle placement can create insufficient force to hold the needle in place during processing and transportation, causing inaccessible needles.Inac cessible needle can also be due to insufficient height of foam.Improvements have been initiated to mitigate this condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 9465705
• Report Number: 1219930-2019-06951
• Device Sequence Number: 2934328
• Product Code: GAM
• UDI-Device Identifier: 10884521048911
• UDI-Public: 10884521048911
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2020

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 Date: 02/28/2023
• Device Model Number: SL-613
• Device Catalogue Number: SL-613
• Device Lot Number: A8B0061FX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1