MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DISPOSABLE KNIFE HOOK 3MM (5); ACCESSORIES,ARTHROSCOPIC

Catalog Number	010600
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the knives cannot longer be bent.They are very rigid and the breakages are frequent, this requires the use of several knives during a single procedure.No patient injuries reported.Back-up device was available.It is unknown if there was a delay of the surgical procedure.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that during the a endoscopic carpal tunel the knives cannot longer be bent.They are very rigid and the breakages are frequent, this requires the use of several knives during a single procedure.No patient injuries or delay reported.Back-up device was available.
Additional Manufacturer Narrative
One disposable 3mm hook knife was returned for evaluation.Visual assessment of the device confirmed the reported complaint.The distal end has broken off.The shaft is bent in multiple location on two planes.Examination of the break area using a stereo microscope confirmed no material voids.The condition of the device indicates the device was subjected to excessive force during use.Per the device ifu 1061352 under precautions: 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 during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.

• Brand Name: DISPOSABLE KNIFE HOOK 3MM (5)
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9336637
• Report Number: 1219602-2019-01447
• Device Sequence Number: 11323590
• Product Code: NBH
• UDI-Device Identifier: 03596010032607
• UDI-Public: 03596010032607
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2019

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 Expiration Date: 04/23/2024
• Device Catalogue Number: 010600
• Device Lot Number: 2031415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 11/18/2019; 11/25/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 11/22/2019; 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1