FDA Adverse Event
Malfunction
Summary report: N
DRILL BIT 2.6MM X 122MM AO FITTING FOR 3.5
MDR report key: 2182169
·
Received June 23, 2011
Report
- Report Number
- 8031020-2011-00144
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Date of Event
- June 8, 2011
- Report Date
- June 10, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
OUR CUSTOMER HAS REPORTED US VIA SALES REP THAT DURING THE SURGERY, ONE OF THE ITEMS (REF.703702; LOT/SN (B)(4)) DID NOT DRILL COMPLETELY. ANOTHER ITEM (REF.703702; LOT/(B)(4)) WAS AVAILABLE AND WAS USED TO CONTINUE THE SURGERY. THE ITEM (SAME LOT/SN) DID NOT DRILL COMPLETELY. IT HAS BEEN ALLEGED BY THE CUSTOMER THAT THE SCREW ENTER WITH NO PROBLEMS AFTER THE DRILL WITH BOTH PRODUCTS. THE ITEMS ARE PARTS OF A LOAN KIT. NO MORE ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DRILL BIT 2.6MM X 122MM AO FITTING FOR 3.5 | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS SELZACH | NA | W06750 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |