FDA Adverse Event
Malfunction
Summary report: N
UNK RESECTION BLOCK
MDR report key: 9215447
·
Received October 21, 2019
Report
- Report Number
- 1818910-2019-110960
- Event Type
- Malfunction
- Date Received
- October 21, 2019
- Date of Event
- September 30, 2019
- Report Date
- September 30, 2019
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
PRODUCT COMPLAINT # (B)(4). THIS IS A DUPLICATE REPORT OF 1818910-2019-110957. 1818910-2019-110960 IS BEING RETRACTED AS IT IS A REPORT DUPLICATION. 1818910-2019-110957 WILL BE KEPT FOR INVESTIGATION.
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.
Description of Event or Problem · 1
DURING A KNEE REVISION THE THREADED HEADED PIN WAS DRILLED THRU THE CUTTING BLOCK AND THE DISTAL AUGMENT. THE PIN IS STILL STUCK IN THE BLOCK. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WERE FRAGMENTS GENERATED? NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1010908 | UNK RESECTION BLOCK | UNK INSTRUMENT | LXH | DEPUY ORTHOPAEDICS INC US |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |