FDA Adverse Event
Malfunction
Summary report: N
2.5MM DRILL BIT/QC/GOLD/180MM
MDR report key: 10560982
·
Received September 21, 2020
Report
- Report Number
- 2939274-2020-04229
- Event Type
- Malfunction
- Date Received
- September 21, 2020
- Report Date
- August 25, 2020
- Manufacturer
- WRIGHTS LANE SYNTHES USA PRODUCTS LLC
- Product Code
- HWE
- UDI-DI
- 10886982186263
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL PRODUCT CODE: GFF GFA HSZ. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.
Description of Event or Problem · 1
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 2.5 MM DRILL BIT WAS BROKEN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY REPORTED. THE PROCEDURE AND PATIENT OUTCOMES WERE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 2.5 MM DRILL BIT/QC/GOLD/180 MM. THIS IS REPORT 1 OF 1 (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1027274 | 2.5MM DRILL BIT/QC/GOLD/180MM | INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH | HWE | WRIGHTS LANE SYNTHES USA PRODUCTS LLC | 310.23 | 10886982186263 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |