MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNIFE RETROGRADE BOXED SET; ARTHROSCOPE

Model Number	4449
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported a clean breakage of the knife retrograde boxed set when used in the operating room.It is unknown whether there was a back up available or delay in the case.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that the metal shaft was broken near the handle, with minimal bending present.There was some discoloration on the handle, but minimal debris.A review of the device 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 review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found the following warnings and precautions related to the reported failure: ¿read these instructions completely prior to use.For single use only.Discard any open, unused product.Do not use after the expiration date.It is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.¿ the complaint was confirmed, but the root cause could not be established.Factors that could have contributed to the reported event include development of a hairline crack in transport, excessive force on the device, use of the device as a lever, or an inadvertent impact event in transport or at the customer site.No containment or corrective actions are recommended at this time.

• Brand Name: KNIFE RETROGRADE BOXED SET
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11164649
• Report Number: 1219602-2021-00119
• Device Sequence Number: 11692480
• Product Code: HRX
• UDI-Device Identifier: 03596010129413
• UDI-Public: 03596010129413
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K954627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2025
• Device Model Number: 4449
• Device Catalogue Number: 4449
• Device Lot Number: 50876027
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention