MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD TI-CRON; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	88863256-51
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Granuloma (1876); Tissue Damage (2104); Tissue Breakdown (2681); No Code Available (3191)
Date of Event	02/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter: a hand extensor tenorrhaphy was performed.Approximately 2 months and 1 week post op the patient had prominicence of the suture.The customer claims that the adverse event happened after tenorrhaphy of hand extensors.After month or two, the suture (the knot of the suture) has been observed to spit out of dermis.There was granuloma formation at the knot site.The suture was routinely hydrated by pooling through the physiological solution.For suturing the hand tendon extensor, they used kessler and/or krakow suturing, pulling the suture several times through the tendon.Removal of the spitted sutures was required to prevent permanent impairment of a function.There was unanticipated tissue loss due to the removal of the spitted suture.There was tissue damage as a result of the problem.The damage was not permanent after the second procedure.There will be an additional operation performed to correct the issue.It led to additional hospital stay.The current patient status is ok.Patient medical history: healthy.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of one device.The visual inspection and functional evaluation of the sample had acceptable results.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TI-CRON
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6608445
• Report Number: 9612501-2017-05571
• Device Sequence Number: 11050016
• Product Code: GAT
• UDI-Device Identifier: 10884521061897
• UDI-Public: 10884521061897
• Combination Product (Y/N): N
• PMA/510(K) Number: K961578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2018

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 Expiration Date: 03/31/2021
• Device Model Number: 88863256-51
• Device Catalogue Number: 88863256-51
• Device Lot Number: D6C2015X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Initial Date Received by Manufacturer: 03/14/2017
• Supplement Date Received by Manufacturer: 03/14/2017; 02/19/2018
• Initial Report FDA Received Date: 06/02/2017
• Supplement Report FDA Received Date: 09/07/2017; 03/07/2018
• 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: Other; Required Intervention