MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPIDER 2 TENET 7615; TABLE, OPERATING-ROOM, ELECTRICAL

Catalog Number	72203299
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Unintended Movement (3026); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a shoulder arthroscopy, the arm of one (1) spider 2 tenet went limp and did not lock, batteries were changed and the problem persisted.The procedure was resumed after a 1-hour surgical delay, by chainging the surgical technique, a second person scrubbed in and held the arm.Additional anesthesia was required as consequence of the surgical prolongation.No further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known risks with the device itself or with its use that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
H11: h2: additional information on b5 & h6 (medical device problem code).
Event or Problem Description
It was reported that, during a shoulder arthroscopy, the arm of one (1) spider 2 tenet started to get slower and then did not lock, batteries were changed and the problem persisted.The procedure was resumed after a 1-hour surgical delay; by changing the surgical technique, a second person scrubbed in and held the arm.Additional anesthesia was required as consequence of the surgical prolongation.No further complications were reported.
Additional Manufacturer Narrative
H11 h3, h6 the reported device was received for evaluation.A visual inspection was performed on the exterior of the device, and no physical damage was observed.A functional evaluation revealed the returned device powers on but failed to pressurize.It's noted that the returned device's battery indicator is a solid green and the arm is limp.Additionally, the device's case was opened and found the device's fuse is good.A bypass device was used and revealed the solenoid works as expected; however, the motor is in bad condition.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause has been associated with a component failure.Factors that could have contributed to the reported event include a failure of the motor.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: SPIDER 2 TENET 7615
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 24038769
• Report Number: 1643264-2026-00014
• Device Sequence Number: 15705891
• Product Code: GDC
• UDI-Device Identifier: 00885554023534
• UDI-Public: 885554023534
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2026

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 Catalogue Number: 72203299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 01/22/2026; 05/11/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 01/29/2026; 05/12/2026
• 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