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	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a hip procedure, the q fix broke when it was being drilled into the patient's bone.The procedure was successfully completed without significant delay using a back-up device.No other complications were reported.
Additional Manufacturer Narrative
H10.H3, h6: the device intended to be used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined.A review of the device history records for the device 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 complaint history review concluded this was an isolated event.A review of the instructions for use found: -prior to use, examine the instrument(s) and check for proper functioning.-the instrumentation is designed for use by surgeons experienced in the appropriate specialized procedures.It is the responsibility of the surgeon to become familiar with the proper techniques.-additional precautions include those applicable to any surgical procedure.In general, careful attention must be paid to asepsis and avoidance of anatomical hazards.Factors that could have contributed to the reported event include: (1) 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.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: 10293082
• Report Number: 3006524618-2020-00513
• Device Sequence Number: 11553992
• Product Code: LXH
• UDI-Device Identifier: 00885556724613
• UDI-Public: 885556724613
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 25-1810
• Device Lot Number: 622880
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 07/18/2020
• Supplement Report FDA Received Date: 08/27/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention