MAUDE Adverse Event Report: ARTHROCARE CORP. SPEEDLOCK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number OM-7500

Device Problems Material Twisted/Bent (2981); Firing Problem (4011)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case- (b)(4).

Event Description

It was reported that during a shoulder arthroscopy procedure, there was a failure of the speedlock implant.The sutures were not pulled into the shaft of the inserter into the implant.There was excessive suture into the joint and there was no salvage.The procedure was successfully completed with non-significant delay using a s+n back-up device.No further complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).H10 h3, h6: the reported device was received for evaluation.A visual evaluation of the device showed it was not received in any original packaging.The wire snare ring and the anchor were not returned.The long snare wire has been coiled up on the suture reel.The distal end of the insertion device is bent.A functional test of device one is not possible since the device is intended for single use.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states based on the information provided, the implantable sutures was retained in the patient¿s joint it was left secure.Furthermore, micro-motion and/or migration of the retained sutures is unlikely.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include issues encountered while loading the suture into the device or introduction into the cavity.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods.No containment or corrective actions are recommended at this time.

Manufacturer Narrative

H10¨ h3, h6¨the reported device was received for evaluation.A visual evaluation of the device showed it was not received in any original packaging.The wire snare ring and the anchor were not returned.The long snare wire has been coiled up on the suture reel.The distal end of the insertion device is bent.A functional test of device one is not possible since the device is intended for single use.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states based on the information provided, a user error was the likely cause of the reported adverse event.Since the implantable sutures was retained in the patient¿s joint it was left secure.Furthermore, micro-motion and/or migration of the retained sutures is unlikely.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force, do not bend or twist the inserter handle during and after insertion as damage to the implant or incomplete insertion may result; the system requires tension to be distributed through the suture ends to achieve suture lock.No containment or corrective actions are recommended at this time.

Manufacturer Narrative

H10: internal complaint reference case (b)(4).H3, h6: the reported device was received for evaluation.A visual evaluation of the device showed it was not received in any original packaging.The wire snare ring and the anchor were not returned.The long snare wire has been coiled up on the suture reel.The distal end of the insertion device is bent.A functional test of device one is not possible since the device is intended for single use.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states based on the information provided, the implantable sutures was retained in the patient¿s joint it was left secure.Furthermore, micro-motion and/or migration of the retained sutures is unlikely.The root cause has been associated with the use of the device.Factors that could have contributed to the reported event include issues encountered while loading the suture into the device or introduction into the cavity.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods.No containment or corrective actions are recommended at this time.

• Brand Name: SPEEDLOCK
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 12821361
• MDR Text Key: 280829796
• Report Number: 3006524618-2021-01022
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556724675
• UDI-Public: 885556724675
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/12/2024

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: 10/01/2023
• Device Catalogue Number: OM-7500
• Device Lot Number: 2062207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 02/26/2024; 03/12/2024; 06/11/2024
• Supplement Dates FDA Received: 02/27/2024; 03/14/2024; 06/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• 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