MAUDE Adverse Event Report: ARTHROCARE CORP. DISPOSABLE KIT FOR 1.8MM SHOULDER Q-FIX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	25-1810
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that, during a mpfl reconstruction surgery using the "1.8mm q-fix anchor disposable kit"; the drill was inserted into the drill guide and drilled the hole.The drill did not come back out of the drill guide.It seemed to have jammed into the drill guide.The procedure was successfully completed without delay significant using a back-up device.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, h3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection of the returned instruments shows a jammed drill guide.During functional evaluation the drill guide was unable to unjam.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.The complaint was confirmed.Factors that could have contributed to the reported event include: excessive force.Poor bone quality.Misalignment of inserter.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records 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 relationship, if any, between the subject device and the reported event 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.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: DISPOSABLE KIT FOR 1.8MM SHOULDER Q-FIX
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 11448953
• Report Number: 3006524618-2021-00295
• Device Sequence Number: 3497199
• Product Code: LXH
• UDI-Device Identifier: 00885556724613
• UDI-Public: 885556724613
• 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,Followup
• Report Date (Section B): 06/14/2021

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: 04/03/2023
• Device Catalogue Number: 25-1810
• Device Lot Number: 2054719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 04/06/2021; 06/11/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/09/2021; 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1