FDA Adverse Event
Malfunction
Summary report: N
ATTUNE SHIM SZ9 6MM
MDR report key: 6820173
·
Received August 25, 2017
Report
- Report Number
- 1818910-2017-23449
- Event Type
- Malfunction
- Date Received
- August 25, 2017
- Date of Event
- July 26, 2017
- Report Date
- September 11, 2017
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- HWT
- UDI-DI
- 10603295133643
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
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
THIS PRODUCT WAS REPORTED IN ERROR. NO PATIENT DEATH, SERIOUS INJURY OR EVIDENCE OF REPORTABLE PRODUCT MALFUNCTION OCCURRED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATTUNE SHIM WAS FOUND BROKE IN QMC SPD DEPARTMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 601847 | ATTUNE SHIM SZ9 6MM | KNEE INSTRUMENTS | HWT | DEPUY ORTHOPAEDICS, INC. | BFA0M4X | 10603295133643 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |