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	01/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported about a disposable kit for 1.8mm q-fix mini suture anchor that during a knee procedure when drilling the hole with drill and drill guide, the drill did not come back out of the drill guide.Therefore, it was tried to pull it out hard and as a consequence, the drill bit came apart in three pieces and could not be able to be removed from the drill guide.The procedure was successfully completed without significant delay using an additional bone hole.A back-up device was available and no patient injuries or other 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
H10: the q-fix 1.8 mini suture anchor disposable kit, used in treatment, was returned for evaluation.A relationship between the device and reported incident was established.From the information provided, ¿during a knee procedure (¿), the drill bit came apart in three pieces and could not be able to be removed from the drill guide." a review of manufacturing records for the reported lot number 2027027 found no non-conformances or anomalies during manufacturing process related to the reported event.A complaint history review found no related failures; this failure mode will be trended to assess for any necessary corrective actions.An incomplete kit has been returned (no obturator).Visual evaluation shows the disposable drill is broken in three parts and stuck inside the drill guide.No manufacturing abnormalities observed.Functional test is not possible due to the damage.The complaint was verified.The root cause could not be determined with confidence; however, factors unrelated to the manufacturing or design of the device that could have contributed to the reported event include: excessive force.No containment or corrective actions are recommended at this time.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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: 9665165
• Report Number: 3006524618-2020-00041
• Device Sequence Number: 19625925
• 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: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

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: 02/02/2022
• Device Model Number: 72290125
• Device Catalogue Number: 72290125
• Device Lot Number: 2027027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1