MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD BIOSYN; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number	SM-5638
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Pain (1994)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, 44 days following an open total knee replacement procedure wherein 4 sutures were used for closure, the p patient was readmitted with knee pain and wound dehiscence; the suture line did not hold.The patient underwent another surgery to resolve the issue.
Additional Manufacturer Narrative
D10 concomitant products: 88863097-71, 88863097-71 ticron* 1 blu 75cm gs25x36 (lot# unknown) cl-830, cl-830 polysorb 2-0 und 75cm gs22 x36 (lot# unknown) cl-964, cl-964 polysorb* 0 und 90cm gs24 x36 (lot# unknown) 88862818-89, 88862818-89 ticron* 5 blu 4x75cm kv40x12 (lot# unknown) sm-5638, sm-5638 biosyn* 3-0 und 75cm p12 x12 (lot# unknown) sm-5638, sm-5638 biosyn* 3-0 und 75cm p12 x12 (lot# unknown) sm-5638, sm-5638 biosyn* 3-0 und 75cm p12 x12 (lot# unknown) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.Four monofilament suture fragments opened by the account without the packaging were available for evaluation.Visual inspection noted that two fragments were monofilament and dyed violet.Unfortunately, these fragments could not be matched with any of the product descriptions reported.It was reported that the suture line did not hold.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: BIOSYN
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19606485
• Report Number: 9612501-2024-01544
• Device Sequence Number: 18194031
• Product Code: GAM
• UDI-Device Identifier: 10884521033085
• UDI-Public: 10884521033085
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SM-5638
• Device Catalogue Number: SM-5638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female