AHTB UNIVERSAL HIP DISTRACTOR
Received Aug 26, 2020 · Event occurred Jul 2, 2020
Report 3003604053-2020-00093 · MDR key 10455135
Device
Generic name
Apparatus, Traction, Non-powered
Manufacturer
Smith & Nephew, Inc.Model number
72203270Catalog number
72203270
Product problems
- Material Too Rigid or Stiff
- Material Too Rigid or Stiff
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Description of Event or Problem
IT WAS REPORTED THE UNIVERSAL HIP DISTRACTOR'S ORANGE KNOB FOR GROSS TRACTION WILL NOT TIGHTEN/LOOSEN. 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
H3, H6: THE DEVICE, WHICH WAS NOT USED IN A PROCEDURE, WAS RETURNED FOR EVALUATION. THERE WAS A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE. VISUAL ASSESSMENT OF THE DEVICE SHOWED THE ORANGE LOCKING KNOB IS SEVERELY DAMAGED. THIS FAILURE IS CAUSED BY CONTACT WITH ANOTHER SOURCE. 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 OTHER RELATED FAILURES. 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. NO FURTHER INVESTIGATION IS REQUIRED.