FDA Adverse Event
Malfunction
Summary report: N
4MM DIAMOND BALL
MDR report key: 3240632
·
Received July 17, 2013
Report
- Report Number
- 1045834-2013-03528
- Event Type
- Malfunction
- Date Received
- July 17, 2013
- Date of Event
- June 1, 2013
- Report Date
- June 17, 2013
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED FROM (B)(6) THAT DURING INCOMING INSPECTION, IT WAS OBSERVED THAT THERE WAS "RESIDUE IN THE STERILE PACKAGE" OF THE DEVICE. THE DEVICE WAS NOT USED IN SURGERY. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THE EXACT DATE OF THE EVENT WAS UNK. ALTHOUGH THE REPORTER CLARIFIED THE EVENT OCCURRED IN (B)(6) 2013. ALL AVAILABLE INFO HAS BEEN DISCLOSED. IF ADDITIONAL INFO SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 331954 | 4MM DIAMOND BALL | HBC | DEPUY SYNTHES POWER TOOLS | E513059139 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |