FDA Adverse Event
Malfunction
Summary report: N
S/C TRIAL HANDLE ANGLED
MDR report key: 7959953
·
Received October 12, 2018
Report
- Report Number
- 1818910-2018-72281
- Event Type
- Malfunction
- Date Received
- October 12, 2018
- Date of Event
- October 5, 2018
- Report Date
- October 5, 2018
- Manufacturer
- DEPUY ORTHOPAEDICS, INC. 181891
- Product Code
- HWA
- UDI-DI
- 10603295084488
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT COMPLAINT (B)(4). 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
PRODUCT COMPLAINT # : (B)(4). THE INSTRUMENT ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. 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 CURVED BIPOLAR HANDLE WILL NOT ACCEPT HEAD TRIALS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 801766 | S/C TRIAL HANDLE ANGLED | HIP INSTRUMENTS : HANDLES | HWA | DEPUY ORTHOPAEDICS, INC. 181891 | PG253500 | 10603295084488 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |