MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION SHARPOINT PLUS; MONODERM 3-0 UNDYED 1X27" PS-1

Model Number	Y936N
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation concluded that the product was used off-label, according to the following instructions for use: indications: monoderm¿ (pga-pcl) suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.Contraindications: this suture, being absorbable, should not be used where extended approximation of tissue under stress is required, such as in fascia.
Event or Problem Description
It was reported on (b)(6) 2024 that a cardiac surgery team encountered issues using monoderm sutures during a median sternotomy closure.The surgeons reported difficulties after several passes with the precision needles, as the needles failed to puncture tissue effectively.After about half a dozen passes, the needles flattened, requiring them to cut, tie, and open a new suture after every inch.The team used three boxes of monoderm sutures during the procedure due to these issues.

• Brand Name: SHARPOINT PLUS
• Common Device Name: MONODERM 3-0 UNDYED 1X27" PS-1
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702 b; tijuana baja california 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; 247 station drive; suite ne1; westwood
• Manufacturer Contact: audrey mudderman ; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana
• MDR Report Key: 20441343
• Report Number: 3010692967-2024-00083
• Device Sequence Number: 8091072
• Product Code: GAM
• UDI-Device Identifier: 00848782021574
• UDI-Public: 00848782021574
• Combination Product (Y/N): N
• PMA/510(K) Number: K052437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2024

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 Model Number: Y936N
• Device Catalogue Number: Y936N
• Device Lot Number: E125EIC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown