MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPIDER FOR JAPANESE/ESCHMANN OR TABLE; ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Catalog Number	72200917
Medical Device Problem Codes	Unstable (1667); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the spider for japanese/eschmann or table could not fixed properly and had a quick connector failure.No case reported; therefore, no patient was involved.
Additional Manufacturer Narrative
The reported 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.The quick connect button was bent.A functional evaluation was performed.The device failed the weight test.The piston migration was at 2.2 inches.The reported complaint of a quick connect failure was confirmed.Factors that could have contributed to the reported complaint include an impact event inconsistent with intended use.The reported failure of "could not be fixed properly" was confirmed and the root cause is associated with a seal failure.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review for "quick connect failure" concluded this was an isolated event.A complaint history review concluded that the "could not be fixed properly" failure was a repeat issue.No containment or corrective actions are recommended at this time.

• Brand Name: SPIDER FOR JAPANESE/ESCHMANN OR TABLE
• Common Device Name: ACCESSORIES, OPERATING-ROOM, TABLE (KIT)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11795353
• Report Number: 1643264-2021-01751
• Device Sequence Number: 4016646
• Product Code: FWZ
• UDI-Device Identifier: 00885554012910
• UDI-Public: 885554012910
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 06/09/2021

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 Catalogue Number: 72200917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 05/08/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1