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

Model Number	7209492
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sliding suture cutter had a sharpness issue, it cannot cut the suture properly.It is unknown whether the event happened during surgery and if there was a patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One 7209492 sliding suture cutter intended for use in treatment, was not returned for evaluation.This is a two year old reusable instrument.Evaluation was limited product.If further information becomes available, the complaint may be revisited.Factors that may affect device performance include: device ability, surgical ability, implant location and tissue condition.Instruments are designed for repeated use with proper care and handling.Demineralized water may help avoid mineral deposits.Antimicrobial lubricant soaks aid with the movement freeing of stiffened instrument parts.Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges.Dulled cutters are subject to malfunction and breakage.Periodic maintenance is recommended.The complaint was not confirmed.Complaint history review indicated no similar allegation for the lot number reported.Batch review indicated no condition, product or procedure failure that supported the allegation.Product met specifications upon release to distribution.Cutting devices are 100% tested prior to release.
Additional Manufacturer Narrative
H10 h3,h6: the reported device, intended for use in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A review of the device history records 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 complaint history review concluded this was an isolated event.A visual inspection revealed the device was returned outside of original packaging.The device is in good condition and doesn't show signs of wear.A functional evaluation revealed the device functioned as intended.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.

• Brand Name: SLIDING SUTURE CUTTER
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10394046
• Report Number: 1219602-2020-01233
• Device Sequence Number: 3446578
• Product Code: NBH
• UDI-Device Identifier: 03596010474568
• UDI-Public: 03596010474568
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2021

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: 7209492
• Device Catalogue Number: 7209492
• Device Lot Number: L868389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 09/03/2020; 05/03/2021
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 09/07/2020; 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1