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

Model Number	72200626
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that the hip distractor was not tightening on the boot holder clamp.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, intended for use in treatment, was received for evaluation and forwarded to the supplier for additional investigation.There was a relationship found between the returned device and the reported incident.The product evaluation confirmed the reported failure.The knob spacer, thrust pivot, handle lock, ball joint lock tube, spherical distractor mount, bellows, barrel nut, mast end cap and clamp bolt required replacement.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.Based on the serial number of this device, the records show that it was manufactured from sep 2012 to oct 2012.The complaint was confirmed.The items identified as needing replacement or repair, have been determined to be from normal wear and tear that is the result of frequent use during this items service life.No containment or corrective actions are recommended at this time.

• 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: 11567860
• Report Number: 3003604053-2021-00118
• Device Sequence Number: 11643181
• Product Code: LXH
• UDI-Device Identifier: 03596010562890
• UDI-Public: 03596010562890
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2021

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: 03/09/2021
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1