MAUDE Adverse Event Report: ARTHROCARE CORP. DISP FIRSTPASS STR PASSR SELF; PASSER

Catalog Number 22-4035

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Scar Tissue (2060); Foreign Body In Patient (2687)

Event Date 05/01/2018

Event Type  Injury  

Event Description

It was reported that patient had a revision surgery to remove scar tissue as a result of the constant pain experienced.Scar tissue is alleged to be the result of the patient having a foreign metallic object which was removed in (b)(6) 2017.Patient had scar tissue and also had a bulbous area of scar tissue at the area of the attachment of the coracoacromial ligament at the anterior aspect of the acromion.

Manufacturer Narrative

The reported disposable firstpass suture passer device, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.From the information provided, ¿patient had a revision surgery to remove scar tissue as a result of the constant pain experienced.Scar tissue is alleged to be the result of the patient having a foreign metallic object¿ an exact root cause cannot be determined without evaluation of the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) excessive force (2) tissue thickness (3) damaged device tip (4) misuse of the device.The instruction for use was reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.The instructions for use states: - inspect the instrument prior to use.Do not use the instrument if it appears defective, damaged, or otherwise compromised.- as with any surgical instrument, care should be taken to ensure that excessive force is not placed on the device.Excessive force can result in failure.- do not use this device as a lever for manipulating hard tissue or bone.Misuse of this device may result in bent or broken distal tip or jaws.- tissue thickness may affect suture placement including stitch depth and needle entry point.- when passing suture multiple times always check the tip of the device for damage or debris between passes.Clear any visible debris between passes.Discontinue use if the device becomes damaged between passes.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.Information corrected.The initial device information reported was not correct as it referred to a device that has no contact with the patient.Information referred to the wrong device as well.

Manufacturer Narrative

The reported firstpass suture passer suture capture device, intended for use in treatment, was returned for evaluation.Visual evaluation of device shows a severely damaged suture capture separated in two pieces.The reported firstpass suture passer suture trap can not be attached to the upper jaw of firstpass suture passer device and tested due to the severe damage.A relationship between the device and reported incident was established.Customer¿s complaint was confirmed.From the information provided, ¿a revision surgery was performed to remove the metallic foreign body, which was identified to be the upper catching jaw of the auto suture firstpass device¿ and ¿patient had a revision surgery to remove scar tissue as a result of the constant pain (the result of the patient having a foreign metallic object) and a bulbous area of scar tissue at the area of the attachment of the coracoacromial ligament at the anterior aspect of the acromion.¿ an exact root cause cannot be determined without evaluation of the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) incorrect suture trap loading.(2) excessive force.(pn 62515 rev.F) was reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.(1) the needle and trap must be inserted to the proper depth and orientation in order to permit the firstpass suture passer to function properly.(2) as with any surgical instrument, care should be taken to ensure that excessive force is not placed on these devices, otherwise, failure may result.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: DISP FIRSTPASS STR PASSR SELF
• Type of Device: PASSER
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8323752
• MDR Text Key: 135616468
• Report Number: 3006524618-2019-00083
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 22-4035
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 03/28/2019; 06/27/2019
• Supplement Dates FDA Received: 03/29/2019; 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR