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

Model Number 72290130

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 07/08/2020

Event Type  Injury  

Event Description

It was reported that during shoulder surgery the top jaw of firstpass mini broke off inside the patient, the broken piece was retrieved with significant difficulty, an extra incision had to be made to remove it.There was a delay greater of 30 min and the procedure was completed using a s+n backup device.No further complications were reported.

Manufacturer Narrative

H10: h2, h6.The device used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined.A review of the device history records for the device showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A review of risk management files found that the reported failure was documented appropriately.A complaint history review concluded this was an isolated event.A review of the instructions for use found: - as with any surgical instrument, care should be taken to ensure that excessive force is not placed on the device.- do not use this device as a lever for manipulating hard tissue or bone.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.-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.Without the reported product a visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.Clinical evaluation was completed.No further complications was reported.The patient is reported as "currently healthy," therefore no further assessment is warranted at this time.Factors that could have contributed to the reported event include: (1) excessive force (2) tissue thickness (3) damage or debris in the device tip between passes.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

Manufacturer Narrative

H10 h3, h6: the reported device, used in treatment, was returned for evaluation.There was a relationship found between the reported incident and the returned device.A review of the device history records for the reported lot number showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found that mishandling the device can result in failure.Clinical evaluation was completed.No further complications was reported.The patient is reported as "currently healthy," therefore no further assessment is warranted at this time.Visual evaluation shows the device broken upper jaw.The device can not be tested due to damaged broken upper jaw.The finger lever and needle performed as intended.The complaint was confirmed.Factors that could have contributed to the reported event include: (1) excessive force (2) tissue thickness (3) damage or debris in the device tip between passes.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: FIRSTPASS MINI RIGHT
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10339925
• MDR Text Key: 200857307
• Report Number: 3006524618-2020-00548
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885556694572
• UDI-Public: 00885556694572
• 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: 02/01/2021

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: 03/01/2022
• Device Model Number: 72290130
• Device Catalogue Number: 72290130
• Device Lot Number: 2029954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 07/29/2020
• Supplement Dates Manufacturer Received: 07/08/2020; 01/27/2021
• Supplement Dates FDA Received: 09/22/2020; 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention