MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN SMITH+NEPHEW DEV; SAW, POWERED, AND ACCESSORIES

Model Number	72202961
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set up or inspection, an unknown device was heating up.There was a s+n back-up device available and no delay was reported.There was no patient involvement.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.Insufficient product identification information was provided and thus a complaint history review could not be conducted.Insufficient product identification information was provided and thus a risk management review could not be conducted.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.Correction in g4 (510k).
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).B5 and d4: updated.Internal complaint reference case-(b)(4).H10: the information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Per an additional response from the complainant, it was confirmed that the correct part number belongs to a videoarthroscope and that the overheating that was initially reported was a mistake, the correct malfunction that took place was a cracked lens and a light adapter that was loose, these malfunctions have not concluded in any damage/intervention to a patient in the past.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly, and a further report submitted outlining both the event details and our investigations performed.
Event or Problem Description
It was reported that during set up or inspection, a videoarthroscope was cracked or had the light adapter loose.There was a s+n back-up device available and no delay was reported.There was no patient involvement.

• Brand Name: UNKN SMITH+NEPHEW DEV
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15746739
• Report Number: 3003604053-2022-00066
• Device Sequence Number: 6241596
• Product Code: HAB
• UDI-Device Identifier: 00885554024159
• UDI-Public: 00885554024159
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2023

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: 72202961
• Device Catalogue Number: 72202961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 06/05/2023; 06/15/2023
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 06/06/2023; 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown