FDA Adverse Event
Malfunction
Summary report: N
QUICKSET TAPER HEX SCDR RIGID
MDR report key: 6784749
·
Received August 10, 2017
Report
- Report Number
- 1818910-2017-22575
- Event Type
- Malfunction
- Date Received
- August 10, 2017
- Report Date
- July 12, 2017
- Manufacturer
- DEPUY ORTHOPAEDICS, INC. 1818910
- Product Code
- HXX
- UDI-DI
- 10603295109235
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Additional Manufacturer Narrative · 1
EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE REPORTED OBSERVATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGID HOX SCREWDRIVER STRIPPED AND WILL NOT WORK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 566164 | QUICKSET TAPER HEX SCDR RIGID | HIP INSTRUMENT/TRIAL | HXX | DEPUY ORTHOPAEDICS, INC. 1818910 | AG0185125 | 10603295109235 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |