MAUDE Adverse Event Report: SMITH & NEPHEW, INC. XL SUTURE CUTTER; ACCESSORIES,ARTHROSCOPIC

Model Number	72202588
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip procedure when the suture cutter cuts it leaves black dust.No delay and a back up was available to complete the procedure.No patient injury was 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: one 72202588 xl suture cutter was returned for evaluation.Visual assessment confirms complaint.The information provided states: ¿during a hip procedure when the suture cutter cuts it leaves black dust¿.Per the device ifu ¿as with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure¿.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of complaints and manufacturing batch records was preformed, no other complaints of this failure was found.Further investigation is not warranted at this time.

• Brand Name: XL SUTURE CUTTER
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9862719
• Report Number: 1219602-2020-00540
• Device Sequence Number: 2533385
• Product Code: NBH
• UDI-Device Identifier: 03596010652430
• UDI-Public: 03596010652430
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

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 Model Number: 72202588
• Device Catalogue Number: 72202588
• Device Lot Number: 49160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1