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

Model Number 72202588

Device Problem Contamination (1120)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/19/2020

Event Type  malfunction  

Event 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.

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
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9862719
• MDR Text Key: 184371801
• Report Number: 1219602-2020-00540
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010652430
• UDI-Public: 03596010652430
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 04/20/2020
• Supplement Dates FDA Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1