MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT, LONG; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number 232448

Device Problem Break (1069)

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

Event Date 12/02/2022

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by a healthcare professional in china that during an unknown procedure on (b)(6) 2022, it was observed that the rigidloop adjustable cortical implant, long device broke off when tightened.Another like device was used to complete the surgery.There were no adverse consequences to the patient nor surgical delay reported.No additional information could be provided.

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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
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> the complaint device is not being returned, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, it appeared that the white suture was broken.It was identified that the distal part was damage, the ends were frayed.This complaint can be confirmed.A manufacturing record evaluation was performed for the finished device 8l79681 number, and no non-conformances were identified.The photo does not provide enough evidence to determine root cause.Physical evaluation should provide more information to discern a possible root cause.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 of adjusting suture loops well 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 103050528, the tension is measured only on the green/white suture (111455) 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 white suture, due to this broken suture can¿t have happened during manufacturing process.It is possibly a result of too much tension on the adjusting suture when attempting to keep the adjustable cortical implant button in place have resulted in fraying; also, could be related to the handling of the device, when inserting through the bone tunnel, the white suture could have rubbed with the bone internal walls.As per ifu: ream 4.5mm passing tunnel and graft socket, 2.If graft socket breaches cortex, use adjustable cortical xl implant to complete reconstruction, 3.Pass implant construct through the bone tunnels using the green-and-white-striped leading suture, 4.Flip the button on the cortex by pulling the green trailing suture and/or the graft.Confirm deployment by toggling leading and trailing sutures or by pulling on graft, 5.While maintaining counter tension on the graft, advance graft into the socket by pulling the white adjustable suture until the graft is fully seated, 6.Fixate opposing end of the graft, 7.Cut the white adjustable suture.8.Cut the green-and-white-striped leading suture, 9.Remove the green trailing suture.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT, LONG
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• 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: 16061182
• MDR Text Key: 308465544
• Report Number: 1221934-2022-04266
• Device Sequence Number: 1
• Product Code: MBI
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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
• Device Operator: Health Professional
• Device Model Number: 232448
• Device Catalogue Number: 232448
• Device Lot Number: 8L79681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 01/02/2023
• Supplement Dates FDA Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female