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

Catalog Number	72200626
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure the device's orange knob was sticking, preventing proper functionality.Instruments had to be retrieved from within the patient because of the malfunction.There was a backup device available.No delay or patient injury was reported.
Additional Manufacturer Narrative
H3, h6: an evaluation was performed by smith and nephew and could confirm the customer complaint for the orange articulating knob on the universal leg is sticking and preventing proper function.A visual inspection was performed and showed the hip distractor is dented indicating hard contact to the device.Functional testing was performed and showed the orange locking knob is disengaged.This device was shipped to the customer on 07/20/2007.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.No manufacturing related defects were observed.

• 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: 8941625
• Report Number: 3003604053-2019-00104
• Device Sequence Number: 13963416
• Product Code: LXH
• UDI-Device Identifier: 03596010562890
• UDI-Public: 03596010562890
• 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): 09/27/2019

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 Catalogue Number: 72200626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1