MAUDE Adverse Event Report: ARTHROCARE CORP. UNKN SPORTS MEDICINE SUTURE DEV; ACCESSORIES,ARTHROSCOPIC

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/13/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that after a rotator cuff repair and regeneten patch on (b)(6) 2020, a second surgery was planned two years later to remove a metal from the shoulder intra articular space.An examination of the removed metal found it to be the capture jaws of the firstpass, these jaws were significantly deformed and covered in soft tissue.The rotator cuff was repaired and there was no evident damage to the shoulder joint.

Manufacturer Narrative

H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A complaint history review found similar reported events.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.Insufficient product identification information was provided and thus a ifu/device labeling review could not be conducted.Insufficient product identification information was provided and thus a risk management review could not be conducted.Smith and nephew has not received the device/adequate clinical information; therefore, without the requested supporting documentation, a thorough medical investigation could not be performed.The root cause and/or patient outcome beyond that which was documented could not be confirmed nor concluded.According to the report, the surgeon reported there was no evident of damage to the patient¿s shoulder, no further medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed, and the root cause could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: UNKN SPORTS MEDICINE SUTURE DEV
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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: 13934252
• MDR Text Key: 288099848
• Report Number: 3006524618-2022-00112
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2022

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 03/28/2022
• Supplement Dates Manufacturer Received: 05/04/2022
• Supplement Dates FDA Received: 05/06/2022
• 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