MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL TRUESPAN 12 DEGREE PEEK; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 228151

Device Problem Mechanical Jam (2983)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

It was reported by the customer in (b)(6) that during a knee arthroscopy with meniscal repair surgery on an unknown date, it was observed that the truespan 12 degree peek device jammed during release.According to the report, there was tear of the meniscus which was no longer suturable.It was further reported that the event could have led to a total tear of the meniscus and the resulting arthrosis with late consequences.The status of the patient postoperatively was unknown.No additional information was provided.

Manufacturer Narrative

Udi: (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.Investigation summary : the device was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.Upon visual inspection, there were no anomalies or structural damage on the outside of the device.Only one implant was received along with the suture.The suture was damage, it was frayed.The red trigger was tested several times and it works as intended.A manufacturing record evaluation was performed for the finished device lot number: [8l25304], and no non-conformances were identified.Based on the condition of the device received, this complaint can be confirmed.There were no details provided as to when this failure has occurred and no additional information was available; therefore, a definite root cause for this failure cannot be determined.The possible root cause for the deployment failure could be related when not inserting the needle to the proper depth for deployment which have caused blocking insertion of the implant, and when this occurred may have felt resistance.The suture and the implants could have been damaged when removing the implants with sharp instruments.As per ifu: it is necessary to use a calibrated probe, measure the width of the meniscal tissue to be repaired and set the adjustable depth.Also, during needle insertion use a malleable graft retractor or slotted cannula to prevent the needle from catching on or damaging soft tissue; once inside the joint space, remove the instrument.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 monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: TRUESPAN 12 DEGREE PEEK
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle CH-24-00 ; SZ CH-2400 ; 6013142063
• MDR Report Key: 13337983
• MDR Text Key: 289192931
• Report Number: 1221934-2022-00280
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026012
• UDI-Public: 10886705026012
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K153667
• 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

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 228151
• Device Catalogue Number: 228151
• Device Lot Number: 8L25304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female