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

Model Number 228151

Device Problems Device-Device Incompatibility (2919); Mechanical Jam (2983)

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

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

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 the sales rep in (b)(6) that during an anterior cruciate ligament with meniscal repair, it was observed that truespan 12 degree peek anchor device did not fire even after repeated attempts at pressing the lever.Another like device was used to complete the procedure with a delay of 5 to 7 minutes.There were no adverse patient consequences reported.No additional information was 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 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: according to the information received, it was reported that during an acl with meniscal repair the doctor used a truespan 12 degree peek implant, and the implant did not fire.He made repeated attempts at pressing the lever, however, the implant did not fire.The surgeon used another truespan which was lying in the ot which worked fine.The angle of the deployment was also okay.The complaint device has not been returned, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, it could be observed that the first plate was not fully deployed due to a very small part of the implant remains inside the applier needle.It was not possible to test functionality to perform the deployment due to the device has not been returned.A manufacturing record evaluation was performed for the finished device lot number:7l19104, and no nonconformances were identified.Based on the condition of the implant, this complaint can be confirmed.The photo do not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.The possible root cause for this issue can be attributed to the handling of the device, the operator did not squeeze the red trigger to its fully position.As per ifu 113244, at desired depth, fully squeeze the red deployment trigger while maintaining depth positioning to deliver the first implant.The implant is fully deployed when you hear an audible ¿click¿.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.

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 for evaluation.Mitek then conducted visual inspection of device received.Upon visual inspection, it was identified that the first plate was not fully deployed due to a very small part of the implant remains inside the applier needle.No structural anomalies that can interfere with a full deployment were found.The functional test was performed to the second plate.The applier needle was introduced into a soft tissue simulator, the red trigger was fully squeezed, the second plate was successfully deployed belong with the first implant; no obstruction or difficulties while deploying.Based on the results of the functional test, this complaint can be confirmed.The possible root cause for the deploy failure reported could be related when not inserting the needle to the proper depth for deployment which have caused blocking insertion of the first implant, and when this occurred may have felt resistance and did not pull the trigger all the way.This would result in the first implant being only partially deployed.Then, when the trigger was pulled again both implants would be deployed at the same time.Also, the trigger might have not fully been pressed until a click sound was heard which could cause the reported failure.However, it cannot be conclusively affirmed.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, it is important to fully squeeze the red deployment trigger while maintaining depth positioning to deliver the first implant.The implant is fully deployed when you hear an audible ¿click¿.Fully release the trigger after deployment.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.

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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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 (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 11740312
• MDR Text Key: 265160299
• Report Number: 1221934-2021-01376
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026012
• UDI-Public: 10886705026012
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K153667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/16/2021

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 Expiration Date: 07/31/2023
• Device Model Number: 228151
• Device Catalogue Number: 228151
• Device Lot Number: 7L19104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 04/28/2021
• Supplement Dates Manufacturer Received: 06/22/2021; 01/11/2022; 01/19/2022
• Supplement Dates FDA Received: 06/23/2021; 01/12/2022; 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2020
• 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