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

Model Number	4448
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during an unknown procedure, when opening the package of the knife triangle boxed set, the tip of the knife was found broken.It is unknown if there was a surgical delay.The procedure was completed using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A complaint history review concluded this was a repeat issue.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.A relationship, if any, between the subject device and the reported event could not be determined.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.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: KNIFE TRIANGLE BOXED SET
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 12330781
• Report Number: 1643264-2021-02256
• Device Sequence Number: 2825507
• Product Code: HRX
• UDI-Device Identifier: 03596010129406
• UDI-Public: 03596010129406
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954627
• 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
• Report Date (Section B): 09/20/2021

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: 4448
• Device Catalogue Number: 4448
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1