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

Model Number	CL-15-MG
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	04/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, 44 days after total knee arthroplasty, the patient felt defect on superomedial border patella, aspirate synovasure was done and the result came out negative for infection.57 days after the original procedure, the patient was brought back to the hospital, the surgery site was checked and no suture was seen.The original absorbable suture that was used to hold the tendon may had broken between 2-3 weeks post-operatively as pt regimen begun to increase.A non-absorbable suture was used to resolve the issue, but the suture broke during hand tying.A product from another manufacturer was used to complete the case.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 11935592
• Report Number: 1219930-2021-02206
• Device Sequence Number: 19932391
• Product Code: GAM
• UDI-Device Identifier: 10884521040243
• UDI-Public: 10884521040243
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CL-15-MG
• Device Catalogue Number: CL-15-MG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 68 YR