MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RFB UNIVERSAL HIP DISTRACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	72200626F
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a hip arthroscopy procedure, at the final closing, the bed collapsed and suddenly fell.The doctors grabbed the patient before touching the floor.Part of the bed had broken, and part bent.The clamp that was connected to the bed rail was broken and the screw that connected the leg to the bed became twisted.No delay was reported and it is unknown how the procedure was completed.No further complications were reported.
Additional Manufacturer Narrative
D4 updated.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.An analysis of the customer provided image found the clamp arms to be bent and broken.A visual inspection found damage to the paint, two of the four arms are bent, and the screw looked to be intact.It was determined the device contributed to the reported event.The complaint was confirmed and the root cause associated with a component failure.Factors that could have contributed to the reported event include overloading of weight on the clamp or an unintended excessive prying force.No containment or corrective actions are recommended at this time.

• Brand Name: RFB UNIVERSAL HIP DISTRACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13847335
• Report Number: 3003604053-2022-00010
• Device Sequence Number: 4668963
• Product Code: LXH
• UDI-Device Identifier: 00885556571439
• UDI-Public: 00885556571439
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2022

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: 72200626F
• Device Catalogue Number: 72200626F
• 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: 02/28/2022
• Supplement Date Received by Manufacturer: 03/18/2022; 04/26/2022
• Initial Report FDA Received Date: 03/22/2022
• Supplement Report FDA Received Date: 03/29/2022; 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 17 YR
• Patient Sex: Male
• Patient Weight: 65 KG