FDA Adverse Event
Malfunction
Summary report: N
ICELOCK 621 RATCHET
MDR report key: 20706662
·
Received November 18, 2024
Report
- Report Number
- 3003764610-2024-00008
- Event Type
- Malfunction
- Date Received
- November 18, 2024
- Date of Event
- August 30, 2024
- Report Date
- November 18, 2024
- Manufacturer
- OSSUR HF
- Product Code
- ISH
- Removal / Correction Number
- 2085446-03/27/2023-001-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
LOCK FAILED TO PROVIDE SECURE SUSPENSION RESULTING IN DISSATISFACTION FROM THE USER. UNHARDENED GUIDE PLATE LIKELY CONTRIBUTED TO PREMATURE WEAR OF LOCK. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO IMPROVE PRODUCT PERFORMANCE. ALL COMPONENTS IN THE LOCK MECHANISM ARE NOW HARDENED DURING MANUFACTURING. RECALL FOR AFFECTED LOTS OF ICELOCK RATCHET 621 DEVICE HAS BEEN COMPLETED, HOWEVER THE CUSTOMER IN QUESTION FILLED OUT A FORM ACKNOWLEDGING THE ISSUE BUT STILL DID NOT REPLACE THE LOCK AND PIN AS WAS REQUESTED IN THE NOTICE. NO FURTHER ACTION IS CONSIDERED WARRANTED.
Description of Event or Problem · 0
LOCK FAILED TO PROVIDE SECURE SUSPENSION RESULTING IN DISSATISFACTION FROM THE USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2036486 | ICELOCK 621 RATCHET | PROSTHETIC LOCK | ISH | OSSUR HF | L-621000 | MX220316 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |