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 Information (3190)
Date of Event	07/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during surgery the q-fix mini broke in 3 pieces when using it for the first time.A blue piece, proximal rod and distal part snapped, the last piece got stuck in the drill guide.All three pieces were successfully recovered, the external pieces were retrieved by hand.There was a delay of under 30 min and the procedure was completed using a s+n backup device.No further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
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 review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found: prior to use, examine the instrument(s) and check for proper functioning.Additional precautions include those applicable to any surgical procedure.In general, careful attention must be paid to asepsis and avoidance of anatomical hazards.An incomplete kit has been returned (no obturator).Visual evaluation shows the disposable drill is broken and stuck inside the drill guide.No manufacturing abnormalities observed.Functional test is not possible due to the damage.The complaint was confirmed.Factors that could have contributed to the reported event include: (1) excessive force (2) improper alignment of the handle.

• 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: 10426279
• Report Number: 3006524618-2020-00653
• Device Sequence Number: 19613525
• Product Code: NBH
• UDI-Device Identifier: 00885556662632
• UDI-Public: 00885556662632
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: 72290125
• Device Catalogue Number: 72290125
• Device Lot Number: 2046673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention