MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL RGDLOOP ADJUSTABLE LONG; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	232448
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.Udi: (b)(4).Investigation summary: the product has not returned to depuy synthes mitek, however a photo was provided for review.The photo investigation revealed that rgdloop adjustable long had the white suture frayed, the green suture had foreign matter, presumably biological matter.No other anomalies could be observed as the suture was tangled.The overall complaint was confirmed as the observed condition of the rgdloop adjustable long would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to procedures variables such as: snaps or other instrument to pull the suture without wrapping the suture around the snaps creates a stress point on the suture, resulting in breaking it.The white suture is used to assembly into a graft construction with provides fixation.The green / white suture is the lead suture due to it is used to pull the implant/ graft construction with tension, the tension values are associated with this final implant assembly; the strength requirement adjusting suture loops from dve testing averaged well over the 250n clinical spec ~1700n.The tension clinical spec is high compared to expected intraoperative loads is 20-50n.Therefore, based on the work instruction of finish goods, the tension is measured only on the green/white suture during the manufacturing process.Regarding the white suture, an inspection is performed during the manufacturing process to check the measurement value and the condition; this information correspond to a process control and it is the document to use to guarantee the inspection of the suture, due to this damage suture can¿t have happened during manufacturing process.As per instructions for use (ifu), the steps for a proper insertion are provided, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes mitek quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
Event or Problem Description
It was reported by the sales rep in china that during a cruciate ligament reconstruction surgical procedure performed on (b)(6) 2024 it was observed that when the rgdloop adjustable long suture device was tightened, the suture was broken off.It was reported that another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary = > the product was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned device.Visual inspection found that rgdloop adjustable long white suture was frayed and broken.Also, foreign matter was on the green suture, presumably biological matter.The overall complaint was confirmed as the observed condition of the rgdloop adjustable long would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to the procedural variables, such handling of the device or product interaction during procedure such as: snaps or other instrument to pull the suture without wrapping the suture around the snaps creates a stress point on the suture, resulting in breaking it.The white suture is used to assembly into a graft construction with provides fixation.The green / white suture is the lead suture due to it is used to pull the implant/ graft construction with tension, the tension values are associated with this final implant assembly; the strength requirement adjusting suture loops from dve testing averaged well over the 250n clinical spec ~1700n.The tension clinical spec is high compared to expected intraoperative loads is 20-50n.Therefore, based on the work instruction of finish goods, the tension is measured only on the green/white suture during the manufacturing process.Regarding the white suture, an inspection is performed during the manufacturing process to check the measurement value and the condition; this information correspond to a process control and it is the document to use to guarantee the inspection of the suture, due to this damage suture can¿t have happened during manufacturing process.As per instructions for use (ifu), the steps for a proper insertion are provided, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: RGDLOOP ADJUSTABLE LONG
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT MITEK; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18852004
• Report Number: 1221934-2024-00767
• Device Sequence Number: 7486154
• Product Code: MBI
• UDI-Device Identifier: 10886705024100
• UDI-Public: 10886705024100
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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: 05/31/2026
• Device Catalogue Number: 232448
• Device Lot Number: 194L224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 03/19/2024; 03/20/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 03/20/2024; 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male