MAUDE Adverse Event Report: ARTHROCARE CORP. QFIX 1.8 MINI SUTURE ANCHOR DISP KIT; ACCESSORIES,ARTHROSCOPIC

Model Number	72290125
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a shoulder arthroscopic stabilization the device broke whilst drilling the first hole.All device fragments were retrieved from within the patient.There was a backup device available.No significant delay or patient injury was reported.
Additional Manufacturer Narrative
The returned device, intended for use in treatment, was returned as an mdr for evaluation.Visual inspection shows an incomplete instrument.The missing parts were not received.The returned part of the instrument shows no manufacturing abnormalities.The returned instrument is a single used device and can only be limited functional tested.The complaint was not verified as the reported issue could not be duplicated.Factors unrelated to the design and manufacture of the device which could have contributed to the complaint event are outlined in the precautionary states in the instruction for use provided with the device associated with set-up and use of the device.Potential factors that could contribute the reported event are: excessive force, not adhere the instructions for use improper alignment of the handle.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
H10: h3,h6: the returned device used in treatment, was returned for evaluation.A relationship between the reported event and the device could not be established.A review of the device history records for the reported lot number 2022649 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 for lot number 2022649 for the past 3 years found no related failures.Visual inspection shows a incomplete instrument.The missing parts were not received.The returned part of the instrument shows no manufacturing abnormalities.The returned instrument is a single used device and can only be limited functional tested.The complaint was not verified as the reported issue could not be duplicated.Factors unrelated to the design and manufacture of the device which could have contributed to the complaint event are (1) excessive force (2) not adhere the instructions for use (3) improper alignment of the handle.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.No containment or corrective actions are recommended at this time.

• Brand Name: QFIX 1.8 MINI SUTURE ANCHOR DISP KIT
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9124910
• Report Number: 3006524618-2019-00486
• Device Sequence Number: 14087759
• Product Code: NBH
• UDI-Device Identifier: 00885556662632
• UDI-Public: 00885556662632
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2021
• Device Model Number: 72290125
• Device Catalogue Number: 72290125
• Device Lot Number: 2022649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 11/22/2019; 02/24/2020
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 11/25/2019; 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1