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 04/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during the surgery the suture capture part of the suture passer broke off.No patient injuries or significant delay reported.Back-up device was available to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

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 2040498 found no non-conformances or anomalies during manufacturing process related to the reported event.A complaint history review found no related failures; this failure mode will be trended to assess for any necessary corrective actions.Review of the product instructions for use found adequate warnings and precautions to prevent damage to the device during use.Risk management documents were reviewed finding no additional risks that require to be added to the reference document.Visual inspection shows no manufacturing abnormalities on the device.The suture capture is missing.During functional evaluation the first step of the trigger performed as specified; pressing the lever the needle was extracted as intended; a further test was made by using an ultratape (cobraid blue 38¿); the needle captured the suture as intended but the suture capture on the top bracket for holding back the suture is missing.The complaint was verified.An exact root cause cannot be determined with confidence; however, 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) damage tip or debris between passes (3) tissue thickness.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Mimb closure - reviewed during mimb.A medical investigation will be performed.Proceed based on information provided/available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by dr.(b)(6), medical director a review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information ,surgical procedure/post-operative care review ,device labeling (including technique guides, ifus, etc.) this complaint from japan reports, ¿that during the surgery the suture capture part of the suture passer broke off.No patient injuries or significant delay reported.Back-up device was available to complete the surgery.¿ no clinical/medical documentation was provided for this investigation.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Per the intake team; all efforts to obtain additional information regarding this complaint did not provide any results.If additional supporting medical documents are received this complaint will be reassessed.

• 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: 10009687
• MDR Text Key: 189357910
• Report Number: 3006524618-2020-00223
• 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
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2022
• Device Model Number: 22-4038
• Device Catalogue Number: 22-4038
• Device Lot Number: 2040498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Date Manufacturer Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other