MAUDE Adverse Event Report: ARTHROCARE CORP. SUTURE CUTTER CLEARCUT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	22-4040
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during a shoulder arthroscopy, it was noticed a metal part floating in the joint.After extracting and analysing the particle, the surgeon suspect it could have detached from the device.There was not a significant delay.A back-up device was available.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The reported suture cutter clearcut device, intended for use in treatment, was returned for evaluation.A relationship between the devices and reported incident was not established.From the information provided, ¿it was reported that a shoulder arthroscopy was performed in order to remove a metal part that was floating in the joint, after extracting and analyzing the particle, the surgeon suspected it could have detached from a smith & nephew suture cutter; nevertheless, it was mentioned that the metal part could have possibly originated from another competitor instrument.The metal part was successfully removed from the patient without any patient injury or complications.¿ customer¿s complaint was not confirmed.There are no visual and functional damage to the device.No manufacturing discrepancies were observed.During the functional evaluation, suture was cut by the device performing as intended.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: (1) improper handling of the device.The ifu was reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.The ifu states: - prior to use, examine the instrument and check for proper functioning.- as with any surgical instrument, care should be taken to ensure that excessive force is not placed on these devices, which can result in failure.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SUTURE CUTTER CLEARCUT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9069978
• Report Number: 3006524618-2019-00451
• Device Sequence Number: 3042212
• Product Code: LXH
• UDI-Device Identifier: 00817470008500
• UDI-Public: 00817470008500
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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 Catalogue Number: 22-4040
• Device Lot Number: 12728B
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1