MAUDE Adverse Event Report: ARTHROCARE CORP. DISPOSABLE KIT 2.8MM SHOULDER Q-FIX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	25-2810
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that during a slap repair, the q-fix went to drill the pilot hole and the drill went into the guide and got stuck in the shaft of the guide, it was remove it safely out of the shoulder, but it broke when tried to dislodge the drill/guide.The procedure was successfully completed without delay using a smith and nephew back up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
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 instrument shows no manufacturing abnormalities.The drill is stuck inside the drill guide.A functional evaluation the drill is lodged inside the drill guide and cannot be removed.A review of the customer provided image shows two product packaging with the same product number 25-2810 and lot number 2062610.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 instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.The complaint was confirmed.Factors that could have contributed to the reported event include: (1) excessive force (2) improper alignment of the handle.No containment or corrective actions are recommended at this time.

• Brand Name: DISPOSABLE KIT 2.8MM 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: 11800990
• Report Number: 3006524618-2021-00593
• Device Sequence Number: 3661330
• Product Code: LXH
• UDI-Device Identifier: 00885556724651
• UDI-Public: 885556724651
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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: 10/21/2023
• Device Catalogue Number: 25-2810
• Device Lot Number: 2062610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/16/2021
• 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: Required Intervention