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

Model Number	SC-543
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: sc-543, sc-543 caprosyn 3-0 und 75cm sc1 x36 (lot#:d2l1162y), sc-543, sc-543 caprosyn 3-0 und 75cm sc1 x36 (lot#:d2l1162y), sc-543, sc-543 caprosyn* 3-0 und 75cm sc1 x36 (lot#:d2l1162y), sc-543, sc-543 caprosyn 3-0 und 75cm sc1 x36 (lot#:d3j1707ry), sc-543, sc-543 caprosyn 3-0 und 75cm sc1 x36 (lot#:d3j1707ry), sc-543, sc-543 caprosyn* 3-0 und 75cm sc1 x36 (lot#:d2l1162y), sc-543, sc-543 caprosyn* 3-0 und 75cm sc1 x36 (lot#:d3j1707ry).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.
Event or Problem Description
According to the reporter during a hip procedure, during suturing, the needle came loose from the thread.The issue occurred on four sutures with the same batch number, another three from a different batch number, and another one from another batch.There was no patient injury.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.Thirty six representative samples were available for evalu ation.Light assisted microscopic inspection of the breathable pouches noted no breaches or damage.The needles were properly parked in the retainers.Inspection of the retainers noted the sutures were properly wound and no damage to the retainer.A tactile and mi croscopic inspection of the first nine sutures were performed with no abnormalities.The foil pouches were inspected and identified no signs of damage or abnormalities.Functional testing of the first nine representative samples noted that the breathable pouches were opened without any tears of the tyvek packaging.The sutures were removed from the retainers without any difficulty.The sutures were loaded onto an instron machine by clamping the needle with a pneumatic grip with a serrated face and the suture end with a pneumatic yarn grip.No suture breakage or fraying was noted while handling/loading the sutures into the instron machine.The instron then pulled the sutures until the needle disengaged from the sutures.The load force at the point of detachment was measured and were found to meet ep mean and individual specifications.For the tenth representative sample, the breathable pouch was opened without any tears of the tyvek packaging.The suture could not be removed from the retainer.Upon opening the retainer, adhesive was noted on the suture.It was reported that the needle had detached.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: the suture was difficult to remove from retainer and there was a foreign object on suture.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.A secondary review of the device history records found no potentially contributing factors.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: CAPROSYN
• 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22783531
• Report Number: 9612501-2025-02154
• Device Sequence Number: 10045675
• Product Code: GAM
• UDI-Device Identifier: 10884521034709
• UDI-Public: (01)10884521034709(17)260731(10)D3H2029Y(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K032586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: SC-543
• Device Catalogue Number: SC-543
• Device Lot Number: D3H2029Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2023
• 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
• Patient Sex: Unknown