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

Model Number 22-4038

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during rotator cuff repair procedure the firstpass suture passer's retrieval jaw was not working correctly, when the instrument was reviewed it was noticed the top jaw snapped and half was no longer there.The broken piece was removed from the patient.The procedure had a delay of under 30 min and it was completed using another firstpass suture passer.No injury to the patient was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3, h6: the device reported, used in treatment, was not returned for evaluation.The relationship between the product and reported incident cannot be established.A visual inspection and functional evaluation cannot be performed and customer´s complaint cannot be confirmed.Potential factors unrelated to the design or manufacture of the device that may lead to the failure reported include, but are not limited to: (1) excessive force.(2) tissue thickness (3) tip 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.

Manufacturer Narrative

H10: the disposable firstpass suture passer device, used in treatment, was returned for evaluation.A relationship between the device and reported incident was established.A review of manufacturing records for the reported lot number found no non-conformances or anomalies during manufacturing process related to the reported event.A complaint history review found no related failures.From the information provided, " the firstpass suture passer's retrieval jaw was not working correctly, when the instrument was reviewed it was noticed the top jaw snapped and half was no longer there." visual inspection shows the suture capture is damaged and half detached; the detached part was not returned with the device.After pressing the lever, the bracket can be closed/opened as specified; there were no manufacturing abnormalities found on the device.The complaint was verified and the root cause could not be determined with confidence.Potential factors unrelated to the design or manufacture of the device that may lead to the failure reported include, but are not limited to: (1) excessive force.(2) tissue thickness.(3) damage or debris on the device tip between passes.No containment or corrective actions are recommended at this time.There were no indications 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: 9903835
• MDR Text Key: 185739350
• Report Number: 3006524618-2020-00139
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: 22-4038
• Device Catalogue Number: 22-4038
• Device Lot Number: 2040225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1