MAUDE Adverse Event Report: ARTHROCARE CORP. DOUBLE FIX KNOTLESS PK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72290143

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 09/24/2020

Event Type  Injury  

Event Description

It was reported that during an arthroscopic labrum repair with rotator cuff tear procedure, when bridged in normal use, the metal tip of the inserter broke off and remained inside the anchor.The metal piece was not retrieved from the patient's anatomy.No delay reported.Surgery was completed using the same device with no other complications reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was not returned for evaluation.However, x-ray images were provided.There was a relationship found between the reported incident and the reported device, based on the images provided.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 complaint history review concluded this was an isolated issue.A review of the instructions for use found that mishandling the device can result in failure.Without the reported product a visual and functional evaluation cannot be performed; however, customer¿s complaint can be confirmed based on the x-ray images provided.They show an foreign material inside the patient's shoulder.Factors that could have contributed to the reported event include: (1) excessive force, (2) misalignment of implant or inserter during and after insertion.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.

• Brand Name: DOUBLE FIX KNOTLESS PK
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10694732
• MDR Text Key: 211853845
• Report Number: 3006524618-2020-00896
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556722497
• UDI-Public: 00885556722497
• Combination Product (y/n): N
• PMA/PMN Number: K153669
• 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: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2022
• Device Model Number: 72290143
• Device Catalogue Number: 72290143
• Device Lot Number: 2036953
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR