MAUDE Adverse Event Report: DEPUY MITEK LLC US TRUESPAN 24 DEGREE PLGA; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 228162

Device Problem Material Deformation (2976)

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

Event Date 04/19/2021

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) the during a anterior cruciate ligament reconstruction procedure on (b)(6) 2021, it was observed that the truespan 24 degree plga device was deformed/bent.Another like device was used to complete the procedure with a delay of five 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 summar according to the information received, it was reported that during,acl (ant.Cruciate ligament) re the truespan 24 degree plga constraint applied (tight knee) on needle to access posterior horn in consequence: the needle broken.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, the observation revealed that the needle was deformed.A manufacturing record evaluation was performed for the finished device lot number: 7l66263 and no nonconformances were identified.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of 100 devices that were released to distribution.Based on the visual inspection of the photo provided, this complaint can be confirmed.Hands on analysis should provide the evidence necessary to confirm the root cause.The possible root cause for the needle damage can be attributed when the needle was inside the joint and the needle tip was maneuver to desired location for optimal approximation, it was leveraged, therefore causing stress and a mechanical deformation.However, it cannot be conclusively affirmed.As per ifu, for the needle insertion, it is necessary use a calibrated probe, measure the width of the meniscal tissue to help insert into the joint.Set the adjustable depth stop to minimize tissue penetration depth.Also, during needle insertion use a malleable graft retractor or slotted cannula to prevent the needle from catching on or damaging tissue.As part of mitek¿s 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, in depuy synthes mitek, additional complaint information monitoring for potential safety.

• Brand Name: TRUESPAN 24 DEGREE PLGA
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11792204
• MDR Text Key: 263439254
• Report Number: 1221934-2021-01456
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026050
• UDI-Public: 10886705026050
• Combination Product (y/n): N
• PMA/PMN Number: K153667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 228162
• Device Catalogue Number: 228162
• Device Lot Number: 7L66263
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1