FDA Adverse Event
Malfunction
Summary report: N
EXCEL T-HANDLE
MDR report key: 7741945
·
Received August 2, 2018
Report
- Report Number
- 1818910-2018-65599
- Event Type
- Malfunction
- Date Received
- August 2, 2018
- Date of Event
- June 20, 2018
- Report Date
- July 7, 2018
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- LXH
- UDI-DI
- 10603295079941
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE COMPLAINT. 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.
Additional Manufacturer Narrative · 1
PRODUCT COMPLAINT # (B)(4). NON-HEALTH CARE PROFESSIONAL.
Description of Event or Problem · 1
EXCEL T HANDLE HAS CRACKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 585020 | EXCEL T-HANDLE | HIP INSTRUMENTS : HANDLES | LXH | DEPUY ORTHOPAEDICS INC US | SO2019042 | 10603295079941 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |