HORIZONTAL SPAR, HIP DISTRACTOR
Received Nov 3, 2020 · Event occurred Oct 7, 2020
Report 0002936485-2020-00450 · MDR key 10782141
Device
Generic name
Apparatus, Traction, Non-powered
Manufacturer
Stryker Endoscopy-san JoseCatalog number
3105000104
Product problems
- Positioning Problem
- Adverse Event Without Identified Device or Use Problem
- Positioning Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.
Description of Event or Problem
IT WAS REPORTED THAT PART OF THE PROCEDURE WAS POSTPONED PER THE SURGEON'S DECISION. PLEASE NOTE THERE WAS NO PATIENT HARM.
Description of Event or Problem
IT WAS REPORTED THAT PART OF THE PROCEDURE WAS POSTPONED PER THE SURGEON'S DECISION. PLEASE NOTE THERE WAS NO PATIENT HARM.
Additional Manufacturer Narrative
THIS DEVICE WAS RECEIVED AT OEM-WOM FOR EVALUATION. BASED ON THE OEM-CMI INVESTIGATION REPORT ATTACHED, THE REPORTED FAILURE ¿ LOCKING IN PLACE ISSUE¿ WAS CONFIRMED. ACCORDING TO CMI: UDI: (B)(4). MANUFACTURING DATE: 07/23/2019. VISUAL AND FUNCTIONAL INSPECTION: H-006 HDF-A-BMS HORZ - BRAKE FEET POP OFF BALL (1 BRAKE). DEVICE IDENTIFICATION: RMA 222. DEVICE HISTORY REVIEW: N/A. INVESTIGATION CONCLUSION: ISSUE IS DUE TO END USER MISHANDLING (TRANSPORTING SYSTEM WITH THE BRAKES ENGAGED). THE DESIGN OF THIS BRAKE IS VERY WEAK, SO IT CAN EASILY BREAK WITH THIS TYPE OF MISUSE. PROBABLE ROOT CAUSE: USER HANDLING, WEAK DESIGN. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.