FDA Adverse Event
Malfunction
Summary report: N
K-WIRE GAMMA 3,2X450 MM
MDR report key: 2945262
·
Received December 21, 2012
Report
- Report Number
- 9610622-2012-00609
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- December 11, 2012
- Report Date
- December 12, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: (B)(4). EXPR NOV 2017. THE REVIEW OF THE MANUFACTURING DOCUMENTS REVEALED NO DEVIATION DURING THE PACKAGING PROCESS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED ACCORDING TO THE INFORMATION AVAILABLE. THE POLLUTION MUST HAVE OCCURRED DURING STERILE PACKAGING PROCESS (SUPPLIER ISSUE) AND WAS NOT DETECTED BY INSPECTION TEAMS. HOWEVER, THE FOUND HAIR HAS TO BE CLASSIFIED AS A NON-CONFORMANCE.
Description of Event or Problem · 1
IN INCOMING INSPECTION AT DISTRIBUTION, IT WAS FOUND THAT THERE WAS A HAIR IN THE PACKAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | K-WIRE GAMMA 3,2X450 MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | K817295/K655585 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |