MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3D SPIDER CONNECTOR TENET 7625; ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Catalog Number	72203239
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a knee scope procedure, the 3d spider connector tenet disconnected; therefore spider device could not stayed together, the leg piece and leg dropped from its desired position.The leg had to be hold in place and the foot of the bed needed to be moved.The procedure was successfully completed using a back-up device.There was no surgical delay and no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).The reported device was received for evaluation.A visual inspection of the returned device finds the device returned without the spiral ring or the o ring on the inner shaft.A functional assessment of the device found it is unable to hold in place without the missing spiral ring and o ring.This failure has been determined to be related to the reported event.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 no 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 was associated with component failure.Factors that could have contributed to the reported event include a failure of the retaining ring after repeated use over time.No containment or corrective actions are recommended at this time.

• Brand Name: 3D SPIDER CONNECTOR TENET 7625
• Common Device Name: ACCESSORIES, OPERATING-ROOM, TABLE (KIT)
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19038889
• Report Number: 1643264-2024-00220
• Device Sequence Number: 7223302
• Product Code: FWZ
• UDI-Device Identifier: 00885554023480
• UDI-Public: 00885554023480
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2024

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: 72203239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2023
• 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