MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ADAPTER RAIL CLAMP(2 UNITS)TENET 7403; ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Model Number	7211097
Medical Device Problem Codes	Unstable (1667); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that, during surgery, the cramp screw thread was wavy and dug.Thus, the cramp was locked and the "t-max" could not be fixed.The procedure was successfully completed without delay using a back-up device.No patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3,h6: the device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A functional evaluation was performed.The t-handle was cross threaded and seized up on one clamp.The reported complaint of a damaged thread screw was confirmed and the root cause is associated with a deformation problem.The reported failure of "cannot be fixed" was confirmed and the root cause is also associated with a deformation problem.Factors that could have contributed to the reported event include an impact event or cross-threading event inconsistent with intended use.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.

• Brand Name: ADAPTER RAIL CLAMP(2 UNITS)TENET 7403
• 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: 11159533
• Report Number: 1643264-2021-00120
• Device Sequence Number: 3719568
• Product Code: FWZ
• UDI-Device Identifier: 03596010538611
• UDI-Public: 03596010538611
• 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): 02/06/2021

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: 7211097
• Device Catalogue Number: 7211097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1