FDA Adverse Event Injury Summary report: N

VITOSS BONE MARROW NEEDLES FENESTRATED 8G X 6

MDR report key: 5448661 · Received February 19, 2016

Report

Report Number: 0002530131-2016-00003
Event Type: Injury
Date Received: February 19, 2016
Date of Event: January 22, 2016
Report Date: January 22, 2016
Manufacturer: STRYKER ORTHOBIOLOGICS-MALVERN
Product Code: KNW
UDI-DI: 07613327123579
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: DEVICE EVALUATION INDICATED; THE RETURNED DEVICE WAS MISSING ITS TOP GREEN HANDLE. THE DEVICE SHOWED LIGHT SCRATCHES ALL THROUGHOUT. THE DISTAL TIP IS NOTED TO BE SLIGHTLY BENT LIKELY DUE TO CONTACT WITH A HARD SURFACE. CONCLUSION: 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 NEEDLE COULD HAVE CONTRIBUTED TO THE BENDING OF THE NEEDLE. THEREFORE; THE LIKELY ROOT CAUSE IS MULTIFACTORIAL.

Description of Event or Problem · 1

IT WAS REPORTED THAT; NEEDLE BENT IN PEDICLE AND COULD NOT REMOVE. COULDN'T PUT A SCREW IN THE PEDICLE WHERE NEEDLE GOT STUCK. SALES REP REPORTED SURGERY WAS COMPLETED BY SKIPPING THAT LEVEL.

Description of Event or Problem · 1

IT WAS REPORTED THAT; NEEDLE BENT IN PEDICLE AND COULD NOT REMOVE. COULDN'T PUT A SCREW IN THE PEDICLE WHERE NEEDLE GOT STUCK. SALES REP REPORTED SURGERY WAS COMPLETED BY SKIPPING THAT LEVEL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
104919	VITOSS BONE MARROW NEEDLES FENESTRATED 8G X 6	BIOPSY INSTRUMENT	KNW	STRYKER ORTHOBIOLOGICS-MALVERN	CHRIS	T1511008	07613327123579

Patients

Seq	Age	Sex	Outcome	Treatment
1	28 YR		Other