MAUDE Adverse Event Report: ARTHROCARE CORP. FIRSTPASS MINI STRAIGHT; ACCESSORIES,ARTHROSCOPIC

Model Number 72290128

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Date 04/06/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during a posterior meniscal root repair using a first pass mini suture passer, redundant meniscal tissue was resected and the tibial insertion point of the root was curetted.The tibial tunnel was prepared using a meniscal root aimer, passing pin, and 4.5mm endoscopic cannulated drill.The first of two mini tapes passed into the meniscus without incident.However, passing the second mini tape took many attempts owing to the tight access for the passer to be able to open over the meniscus and then pass the needle without hitting the femoral condyle.Ultimately the second mini tape passed into the meniscus between the initial mini tape and the lateral endpoint of meniscal tissue.The tape ends then shuttled down the tibial tunnel and loaded into a footprint 5.5mm anchor for fixation.The footprint anchor was inserted into the tibia and tape limbs tensioned; however, these tape limbs pulled out of meniscal tissue rendering repair useless.Passing a new mini-tape was attempted, access proved difficult and after several attempts, the mini tape appeared to fire through the meniscus.Upon pulling to jaws of the first pass mini into the joint space it was noticed that the capture mechanism (capture plate) had detached from the upper jaw of the passer and was attached to the suture tape.The surgeon removed the mini-tape from the joint.Upon inspection of the tape, the capture plate was not visible.The sterile field was searched, and the surgeon undertook a thorough arthroscopic search of the knee joint, but the capture plate couldn't be seen.The capture plate is possibly in the soft tissue between knee joint and skin.The surgeon inspected the jaws of the first pass mini and when he touched the upper jaw part, this one broke off.A second first pass mini was then opened and the mini-tape successfully passed.The strength of the hold of the mini tape in the meniscus was tested and the mini tape was again pulled out of the tissue.This resulted in a non-significant surgical delay and the procedure was successfully completed by applying a change in surgical technique.No further complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H2: additional information in b5 (describe event or problem) & h6 (health effect - clinical code).

Event Description

It was reported that during a posterior meniscal root repair using a firstpass mini suture passer, redundant meniscal tissue was resected and the tibial insertion point of the root was curetted.The tibial tunnel was prepared using a meniscal root aimer, passing pin, and 4.5mm endoscopic cannulated drill.The first of two mini tapes passed into the meniscus without incident.However, passing the second mini tape took many attempts owing to the tight access for the passer to be able to open over the meniscus and then pass the needle without hitting the femoral condyle.Ultimately the second mini tape passed into the meniscus between the initial mini tape and the lateral endpoint of meniscal tissue.The tape ends then shuttled down the tibial tunnel and loaded into a footprint 5.5mm anchor for fixation.The footprint anchor was inserted into the tibia and tape limbs tensioned; however, these tape limbs pulled out of meniscal tissue rendering repair useless.Passing a new mini-tape was attempted, access proved difficult and after several attempts, the mini tape appeared to fire through the meniscus.Upon pulling to jaws of the firstpass mini into the joint space it was noticed that the capture mechanism (capture plate) had detached from the upper jaw of the passer and was attached to the suture tape.The surgeon removed the mini-tape from the joint.Upon inspection of the tape, the capture plate was not visible.The sterile field was searched, and the surgeon undertook a thorough arthroscopic search of the knee joint, but the capture plate couldn't be seen.The capture plate is possibly in the soft tissue between knee joint and skin.The surgeon inspected the jaws of the firstpass mini and when he touched the upper jaw part, this one broke off.A second firstpass mini was then opened and the mini-tape successfully passed.The strength of the hold of the mini tape in the meniscus was tested and the mini tape was again pulled out of the tissue.This resulted in a non-significant surgical delay and the procedure was successfully completed by applying a change in surgical technique.A piece of the device was left in the patient and no further complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A complaint history review found similar reported events.This case reports, after several failed attempts using the firstpass mini device the upper jaw part of the second firstpass mini device ¿broke off¿ and a piece was left in the patient.The surgeon reports the ¿broken capture plate is possibly in the soft tissue between knee joint and skin.¿ although requested, no images were provided for review.Based on the limited information provided we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.The ifu cautions, when passing the suture multiple times always check the tip of the device for damage or debris between passing.Clear any visible debris between passes.Excessive force should not be applied to the device when manipulating soft tissue, bone, or hard objects.Misuse of this device may result in bent or broken distal tip or jaws.The firstpass mini suture passer is manufactured and intended as externally communicating devices and are not approved for long term internal tissue exposure and long-term implantation data is not available.The patient impact beyond possible micro-motion and/or migration, and local irritation/discomfort cannot be determined.¿the surgeon deemed the tissue too damaged and friable to tolerate any tension and facilitate a repair¿; therefore, the procedure was cancelled.No information on how the meniscal repair is being treated has been provided.No further medical assessment can be rendered at this time.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.Corrected information in h6 (health effect - impact code).

• Brand Name: FIRSTPASS MINI STRAIGHT
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14219863
• MDR Text Key: 290170401
• Report Number: 3006524618-2022-00218
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885556694558
• UDI-Public: 00885556694558
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2023
• Device Model Number: 72290128
• Device Catalogue Number: 72290128
• Device Lot Number: 2063843
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 04/27/2022
• Supplement Dates Manufacturer Received: 05/01/2022; 07/25/2022
• Supplement Dates FDA Received: 05/04/2022; 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2020
• 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 Outcome(s): Other; Required Intervention