FDA Adverse Event
Other
Summary report: N
ARROW
MDR report key: 3311030
·
Received July 15, 2013
Report
- Report Number
- 3007605810-2013-00001
- Event Type
- Other
- Date Received
- July 15, 2013
- Date of Event
- June 25, 2013
- Report Date
- June 25, 2013
- Manufacturer
- FHI
- Product Code
- HSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE OPERATOR MADE A MISTAKE WHEN PREPARING THE COMPONENT. HE TOOK REFERENCE 26544 INSTEAD OF 265145. WE CHECKED NO OTHER DELIVERED OR IN-PROCESS BATCH PRESENTS THE SAME ERROR. SEE SCANNED PAGE.
Description of Event or Problem · 1
THE PART HAS 2 COMPONENTS. THE POLYETHYLENE ONE IS NOT THE RIGHT SIZE ONE (39/00) INSTEAD OF (39/05). THE DIFFERENCE BETWEEN BOTH IS THICKNESS. THE THICKNESS IS NOT AN ATTRIBUTE THAT PREVENT THE ASSEMBLY. NB: THE BATCH INCLUDES 20 PARTS. NON WAS SENT TO THE USA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 328156 | ARROW | STD HUMERAL INSERT 39/05 | HSD | FHI | B04116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |