MAUDE Adverse Event Report: DFINE INC. STABILIT INTRODUCER BEVEL TIP

Catalog Number 1488 (3961)

Device Problems Bent (1059); Difficult to Remove (1528); Material Twisted/Bent (2981)

Patient Problem Anemia (1706)

Event Date 05/20/2015

Event Type  malfunction  

Event Description

Incident summary: the working cannula of the stabilit introducer bevel tip (pn 3961) bent during the procedure and got stuck.The stylet of the stabilit introducer bevel tip (pn 3961) and the midline osteotome were subsequently difficult to insert and remove from the working cannula after it had been bent.An oncontrol biopsy needle was used to drill into the vertebra adjacent to the stabilit introducer to help dislodge the device from the pt.The density of the bone was noted to be hard / dense.Returned goods: (b)(4), pn 1488, stabilit introducer bevel tip (vm pn 3961) was returned for eval and analysis on 06/16/2015.Investigation: the complaint reported that the working cannula of the stabilit introducer bent during its insertion resulting in it getting lodged in the pt.The device was inspected for any sign of damage.Photo#1 and #3 in the investigation show the distal end of the working cannula of the stabilit introducer was bent.The physician advanced the stabilit working cannula over an exchange wire without the stabilit introducer stylet until it met resistance in dense bone and doing so inadvertently bent the working cannula.The physician then had difficulty inserting the stabilit stylet into the working cannula and removing the working cannula from the pt.Per ifu 1523, warning #6: the introducer stylet or locking delivery cannula should be inserted and engaged with the working cannula during introducer removal or manipulation.The physician's complaint was confirmed.Case details: the physician was initially using another company's (oncontrol) bone drill and introducer.; after using the oncontrol bone drill, the physician removed the bone drill, leaving the oncontrol introducer in the vertebra; the physician inserted a k-wire down that introducer into the vertebra to enable an over the wire exchange of introducers; the physician removed the oncontrol introducer, leaving the k-wire in place; the physician passed the dfine stabilit working cannula over the k-wire to fain access into the vertebra; the physician then pulled the k-wire out and advanced the stabilit working cannula (without the stabilit stylet) until it met resistance.The bone was considered dense.

Manufacturer Narrative

Dhr review: pn 3353, stabilit first fracture kit, short, (blister pack), revision ag, lot 150507a02 ((b)(4)); pn 3352, first fracture kit, blister pack sterile, short, revision ag, lot m209497 ((b)(4)); pn 1488 (vm pn 3961), ((b)(4), assembly pn 39-03961-00z-50), assembly of introducer, bevel tip, short - vm, revision c, lot m209336 ((b)(4)); pn 1688, stabilit er2 bone cement and saturate mixing system, revision ae, lot df060 ((b)(4)); zero anomalies were related to the customer complaint upon review of the dhr documentation.Tests reviewed: (b)(4), rev aq - end item audit testing - 1 test sample, testing specs were all met for the introducer bevel tip.Review of (b)(4), revision bb, hazard 3.2.4.3.1, broken locking delivery cannula or introducer resulting difficulty to remove or unable to remove from pt, treatment delay.Raw material eval of device: pnps 3760 revision ab, introducer, bevel tip, short (vm) linked to material specsl (b)(4) revision ac, stabilit introducer stylet rod, bevel tip, short; requires the raw material (b)(4).Medical grade 316 stainless steel; similar to pedicle screws, are commonly used as permanent implants in fusion spine surgery.

• Brand Name: STABILIT INTRODUCER BEVEL TIP
• Type of Device: INTRODUCER
• Manufacturer (Section D): DFINE INC.; 3047 orchard parkway; san jose CA 95134
• Manufacturer Contact: jason brown ; 3047 orchard parkway; san jose, CA 95134 ; 4083219999
• MDR Report Key: 4862922
• MDR Text Key: 17692815
• Report Number: 3006396387-2015-00007
• Device Sequence Number: 1
• Product Code: GFI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 1488 (3961)
• Device Lot Number: M209336
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/20/2015
• Initial Date FDA Received: 06/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 90