FDA Adverse Event
Injury
Summary report: N
CLAVICLE PIN ASSEMBLY 2.5MM
MDR report key: 1031815
·
Received April 17, 2008
Report
- Report Number
- 1818910-2008-01399
- Event Type
- Injury
- Date Received
- April 17, 2008
- Date of Event
- February 29, 2008
- Report Date
- March 26, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- JDW
- PMA / PMN Number
- K991649
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EXAMINATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFO PROVIDED, AS THE LOT NUMBER REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY WARSAW CONSIDERS THE INVESTIGATION CLOSED. SHOULD THE PRODUCT AND/OR ANY ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.
Description of Event or Problem · 1
CLAVICAL PIN BROKE. REMOVED IN PHYSICIAN'S OFFICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLAVICLE PIN ASSEMBLY 2.5MM | 87JDW | JDW | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Required Intervention |