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

Model Number	72200626
Medical Device Problem Codes	Break (1069); Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during a hip scope, the universal hip distractor knob broke when it was turned.There was a loss of traction as a result of the knob's malfunction.The procedure was successfully completed without delay using the same device.No patient injury 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
H10, h3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed the device revealed a torn bellows, scratched mast and carriage, and the plastic distractor control knob was broken off.The device could not be functionally tested due to the broken knob.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 concluded this was a repeat issue.The complaint was confirmed.Factors that could have contributed to the reported event include an application of excess torque to the control knob or an impact event inconsistent with normal use.Please note, turning the knob allows for repositioning of the device and can contribute to a loss of traction.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.

• Brand Name: UNIVERSAL HIP DISTRACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11366028
• Report Number: 3003604053-2021-00054
• Device Sequence Number: 11758510
• Product Code: LXH
• UDI-Device Identifier: 03596010562890
• UDI-Public: 03596010562890
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

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: 72200626
• Device Catalogue Number: 72200626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1