MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPIDER 2 BATTERY TENET 7609; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	72203301
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during set up or inspection for an arthroscopy, the battery in the spider 2 battery tenet appears to be making a humming sound when plugged into the spider, it's also no longer holding any charge even though it been on charge over night.The procedure was successfully completed without delay using a back-up device.No patient involved at the moment of the incident.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, intended for use in treatment, was not returned to the designated complaint facility for independent evaluation, thus visual inspection and functional testing could not be performed.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.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.
Additional Manufacturer Narrative
The device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issues were observed.A functional evaluation was performed.The device was charged on a known good test charger for approximately four hours.The device was placed on a test spider 2.The device appeared to lose a significant amount of power after about 10 cycles of the test spider 2.The complaint was confirmed and the root cause is an energy storage problem.Factors that may have contributed to the reported failure include, an electro-chemical change in the anode and cathode over time.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.No containment or corrective actions are recommended at this time.

• Brand Name: SPIDER 2 BATTERY TENET 7609
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11783053
• Report Number: 1643264-2021-01699
• Device Sequence Number: 3659854
• Product Code: GDC
• UDI-Device Identifier: 00885554023503
• UDI-Public: 00885554023503
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/24/2021

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: 72203301
• Device Catalogue Number: 72203301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 06/03/2021; 09/02/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/22/2021; 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1