FDA Adverse Event
Malfunction
Summary report: N
DLC DEPTH GAUGE
MDR report key: 7889444
·
Received September 19, 2018
Report
- Report Number
- 1818910-2018-69767
- Event Type
- Malfunction
- Date Received
- September 19, 2018
- Date of Event
- August 6, 2018
- Report Date
- August 27, 2018
- Manufacturer
- DEPUY ORTHOPAEDICS INC US 1818910
- Product Code
- HJT
- UDI-DI
- 10603295109198
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
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. DEPUY ORTHOPAEDICS, INC. (B)(4). 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
SPRING ON DEPTH GAUGE DEFECTIVE. NO DELAY. NO PATIENT HARM. PATIENT CONSEQUENCE? :NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 733422 | DLC DEPTH GAUGE | HIP INSTRUMENTS : DRILL GUIDES | HJT | DEPUY ORTHOPAEDICS INC US 1818910 | AG2018471 | 10603295109198 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |