MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NON OPERATIVE ARM BOARD TENET 7437; ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Model Number	72203415
Medical Device Problem Code	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
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during set up or inspection, the wing screw of the arm board tenet was stripped and won't tighten.The procedure was completed with a s+n back-up device.No delay was reported, and no patient injury or other complications were reported.
Additional Manufacturer Narrative
H3, h6: 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.No issues were noted.A functional evaluation was conducted.The t-handle bolt was stripped and would not tighten.The complaint was confirmed.Factors that could have contributed to the reported event include an an application of force inconsistent with intended use or a mis-threading of the bolt.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 concluded this was a repeat issue.No containment or corrective actions are recommended at this time.

• Brand Name: NON OPERATIVE ARM BOARD TENET 7437
• 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: 11817215
• Report Number: 1643264-2021-01807
• Device Sequence Number: 16949582
• Product Code: FWZ
• UDI-Device Identifier: 00885554023527
• UDI-Public: 00885554023527
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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,consum
• Initial Reporter Occupation: Other Health Care Professional
• 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 Model Number: 72203415
• Device Catalogue Number: 72203415
• Device Lot Number: 7437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 05/13/2021
• 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