FDA Adverse Event
Malfunction
Summary report: N
DIAM 4.3MM SHORT DRILL
MDR report key: 4110626
·
Received September 16, 2014
Report
- Report Number
- 9615741-2014-00041
- Event Type
- Malfunction
- Date Received
- September 16, 2014
- Date of Event
- August 22, 2014
- Report Date
- August 22, 2014
- Manufacturer
- NEWDEAL SAS
- Product Code
- HTW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem · 1
IT WAS REPORTED TIP OF DRILL FELL OFF DURING DRILLING IN PT BONE. TIP POSSIBLY IN THE PT. THE DRILL WAS DISCARDED. ADD'L INFO WAS RECEIVED ON (B)(4) 2014 - THE SURGERY DATE WAS (B)(4) 2014. SURGERY WAS A METATARSOPHALANGEAL JOINT (MPJ) FUSION. THE PIECE OF DRILL THAT BROKE OFF WAS NOT FOUND NOR WAS IT SEEN IN X-RAY TAKEN POST OP. NO ADVERSE CONSEQUENCES TO PT OR INJURY REPORTED. DRILL (REMAINING) WAS DISCARDED AND THE LOT NUMBER WAS NOT KNOWN OR PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 571724 | DIAM 4.3MM SHORT DRILL | NA | HTW | NEWDEAL SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |