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

Model Number	72200626
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during set up or inspection of the universal hip distractor before arthroscopy procedure, it was noticed that the carriage thread of the lag "screw" had been removed, due to this no traction could be applied.The patient was already anesthetized and the surgery was postponed 4 hours later in the same day.Due to the malfunction / defect, the leg couldn¿t have been brought into extension.A replacement has been delivered intraday within 4 hours.Therefore the surgery has been canceled and postponed for the afternoon.The procedure was finished with a smith and nephew backup device.Patient injuries were not reported.
Additional Manufacturer Narrative
The reported device, intended for use in treatment was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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 review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
H6: component code.

• Brand Name: 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: 12733630
• Report Number: 3003604053-2021-00254
• Device Sequence Number: 11126438
• Product Code: LXH
• UDI-Device Identifier: 03596010562890
• UDI-Public: 03596010562890
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72200626
• Device Catalogue Number: 72200626
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 11/22/2021; 03/16/2022
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 12/01/2021; 03/16/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown