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

Catalog Number 232448

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2024

Event Type  malfunction  

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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: e3: reporter is a j&j sales representative.(b)(4) 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 sutures and button were returned.Suture had foreign matter, presumably biological matter.Neither the implant not the suture showed structural anomalies.The overall complaint was unconfirmed as the observed condition of the rgdloop adjustable long would not 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.As per the instructions for use, 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.Device history review indicates that there was no non conformance regarding this lot.

Event Description

It was reported by the healthcare professional in china that during an unspecified surgical procedure, the rgdloop adjustable long device suture could not tightened.During an in-house engineering evaluation, it was determined that the device had foreign substance/debris.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: RGDLOOP ADJUSTABLE LONG
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; 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: 18857476
• MDR Text Key: 337515723
• Report Number: 1221934-2024-00786
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705024100
• UDI-Public: 10886705024100
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K140324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 232448
• Device Lot Number: 194L224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1