MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MONOSOF; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	SN-667
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Codes	Tissue Damage (2104); Rupture (2208); No Code Available (3191)
Date of Event	08/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter post operative an hand surgery for a flexor tendon repair zone 2 in the little finger, during the revalidation of the patient 3-4 weeks after the surgery the flexor tendon ruptured again and the suture broke.The patient will need a extensive new surgery to repair the flexor tendon.A 2 stage flexor tendon reconstruction.The patient will be readmitted to the hospital due to the device malfunction.There was unanticipated tissue loss and tissue damage due to device issue.The incision was extended by more 1 inch, due to device problem.

• Brand Name: MONOSOF
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 8978848
• Report Number: 9612501-2019-01707
• Device Sequence Number: 3275001
• Product Code: GAR
• UDI-Device Identifier: 10884521079830
• UDI-Public: 10884521079830
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K900531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2019

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: SN-667
• Device Catalogue Number: SN-667
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 09/10/2019
• 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