FDA Adverse Event
Malfunction
Summary report: N
VITOSS BONE MARROW NEEDLES 8G X 6
MDR report key: 5514512
·
Received March 21, 2016
Report
- Report Number
- 0002530131-2016-00007
- Event Type
- Malfunction
- Date Received
- March 21, 2016
- Date of Event
- February 24, 2016
- Report Date
- February 24, 2016
- Manufacturer
- STRYKER ORTHOBIOLOGICS-MALVERN
- Product Code
- KNW
- UDI-DI
- 07613327123562
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: DEVICE HISTORY REVIEW INDICATED ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. PER SALES REP, THE REPORTED DEVICE WAS HAMMERED WITH NORMAL FORCE AND PATIENT'S BONE QUALITY WAS NORMAL. THE PATIENT'S BONE QUALITY, THE MOTION USED WHEN INSERTING THE NEEDLE, THE FORCE USED DURING INSERTION AND/OR FORCE USED DURING REMOVAL OF THE REPORTED NEEDLES COULD HAVE CONTRIBUTED TO THE BENDING OF THE NEEDLE. CONCLUSION: THE LIKELY ROOT CAUSE OF THE REPORTED EVENT IS MULTIFACTORIAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TWO NEEDLES BENT UPON INSERTION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TWO NEEDLES BENT UPON INSERTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171085 | VITOSS BONE MARROW NEEDLES 8G X 6 | BIOPSY INSTRUMENT | KNW | STRYKER ORTHOBIOLOGICS-MALVERN | T1511005 | 07613327123562 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |