FDA Adverse Event
Injury
Summary report: N
AIMING ARM
MDR report key: 2171337
·
Received July 18, 2011
Report
- Report Number
- 8030965-2011-00506
- Event Type
- Injury
- Date Received
- July 18, 2011
- Date of Event
- April 7, 2011
- Report Date
- June 21, 2011
- Manufacturer
- SYNTHES GMBH
- Product Code
- JDS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION COORDINATED BY SYNTHES GMBH. REPORT RECEIVED INDICATES THE DEVICE IS BROKEN IN THE AREA OF THE TWO RECON HOLES. NO PRODUCT FAULT COULD BE DETECTED.
Description of Event or Problem · 1
DURING A NAILING PROCEDURE, THE PROXIMAL HOLE OF THE AIMING DEVICE DID NOT ALIGN WITH THE HOLE OF THE NAIL. SURGICAL INTERVENTION REQUIRED TO COMPLETE PROCEDURE. PATIENT EXPERIENCED LONGER THAN EXPECTED HOSPITAL STAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AIMING ARM | AIMING ARM | JDS | SYNTHES GMBH | 2071838 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |