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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that, the arm board of the "non operative arm board tenet" was coming apart of the metal part.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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.No issues were noted.A functional evaluation was conducted.The t-screw threads were stripped.The t-screw could not be tightened.The t-screw was just dangling in the screw hole.The complaint was confirmed.Factors that could have contributed to the reported event include an impact event inconsistent with intended use or a cross threading of the screw threads upon tightening.No 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.

• 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: 10912527
• Report Number: 1643264-2020-01937
• Device Sequence Number: 3056172
• Product Code: FWZ
• UDI-Device Identifier: 00885554023527
• UDI-Public: 00885554023527
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1