FDA Adverse Event
Malfunction
Summary report: N
THE SIMPLE LOCKING INTRA MEDULLARY (SLIM) SYSTEM
MDR report key: 15160573
·
Received August 3, 2022
Report
- Report Number
- 3000327445-2022-00002
- Event Type
- Malfunction
- Date Received
- August 3, 2022
- Report Date
- August 3, 2022
- Manufacturer
- PEGA MEDICAL INC
- Product Code
- HSB
- UDI-DI
- 07540194003942
- PMA / PMN Number
- K192710
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
AN OLD VERSION OF THE SLIM NAIL WAS USED AND THE INFORMATION ABOUT THE SIZES OF THE INTERLOCKING HOLES PROVIDED TO THE COMPANY REPRESENTATIVE WAS INACCURATE.
Description of Event or Problem · 0
DURING A SURGERY USING A Ø5.6MMX340MM SLIM NAIL, THE CORRESPONDING PEG SIZE DID NOT FIT INTO THE DISTAL AND PROXIMAL HOLES FOR FIXATION. THE SURGEON DECIDED TO USE ANOTHER DEVICE FOR INTERLOCKING IN THIS PATIENT. THE SLIM NAIL USED WAS FROM A PREVIOUS VERSION OF THE NAIL WITH SMALLER INTERLOCKING HOLES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1703857 | THE SIMPLE LOCKING INTRA MEDULLARY (SLIM) SYSTEM | SLIM ROD Ø5.6MMX340MM | HSB | PEGA MEDICAL INC | SLM-56-340 | 150105-095 | 07540194003942 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |