FDA Adverse Event
Malfunction
Summary report: N
ATTUNE MOD POST SAW CAP SZ9-10
MDR report key: 8094176
·
Received November 21, 2018
Report
- Report Number
- 1818910-2018-76116
- Event Type
- Malfunction
- Date Received
- November 21, 2018
- Date of Event
- November 14, 2018
- Report Date
- November 14, 2018
- Manufacturer
- DEPUY IRELAND 9616671
- Product Code
- LHX
- UDI-DI
- 10603295130543
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT. 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 RED TAB BROKE OFF OF THE SAW CAPTURE WHILE USING IT TO PREPARE THE FEMUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 936066 | ATTUNE MOD POST SAW CAP SZ9-10 | ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES | LHX | DEPUY IRELAND 9616671 | PG245196 | 10603295130543 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |