AHTB UNIVERSAL HIP DISTRACTOR
Received Jul 7, 2020 · Event occurred Jun 16, 2020
Report 3003604053-2020-00060 · MDR key 10242718
Device
Generic name
Apparatus, Traction, Non-powered
Manufacturer
Smith & Nephew, Inc.Model number
72203270Catalog number
72203270
Product problems
- Mechanical Jam
- Mechanical Jam
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Description of Event or Problem
IT WAS REPORTED THAT, THE "AHTB UNIVERSAL HIP DISTRACTOR" WAS LOCKED. 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
H10 H3,H6: THE DEVICE, WHICH WAS NOT USED IN A PROCEDURE, WAS NOT RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A RELATIONSHIP, IF ANY, BETWEEN THE DEVICE AND THE REPORTED INCIDENT COULD NOT BE CONFIRMED. 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 NO RELATED FAILURES; THIS FAILURE MODE WILL BE TRENDED TO ASSESS FOR ANY NECESSARY CORRECTIVE ACTIONS. FACTORS THAT ARE KNOWN TO CONTRIBUTE TO THE ALLEGED FAULT/FAILURE MAY INCLUDE MISHANDLING DURING SHIPPING, USE OR REUSE OF THE DEVICE, CONTACT WITH ANOTHER SOURCE, OR WEAR AND TEAR OVER TIME. IF THE PRODUCT IS RETURNED IN THE FUTURE THE COMPLAINT CAN BE REOPENED AND EVALUATED.