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)
Date of Event	04/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the universal hip distractor popped out of position when distracting, no pieces fell inside the patient.There was a delay greater than 30 minutes and it is unknown how the procedure was completed.No 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, which was used in a procedure, was returned for evaluation.There was a relationship between the reported event and the device.A visual inspection was performed and showed the universal hip distractor is in poor condition.The bellow is missing, the ball joint is severely rusted, the protective caps and handles are broken and dented, the orange locking knob that connects to the ball joint is disengaged and dented.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found other related failures.The root cause for this failure is contact with another source and wear from use.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: 10139630
• Report Number: 3003604053-2020-00052
• Device Sequence Number: 2101574
• Product Code: LXH
• UDI-Device Identifier: 03596010562890
• UDI-Public: 3596010562890
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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: 06/03/2020
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1