MAUDE Adverse Event Report: SYNTHES MONUMENT HOLDING SLEEVE-LONG FOR MATRIX; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number 03.632.036

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Device history records was conducted.The report indicates that the dhr review part number: 03.632.036 lot number: 7506718 release to warehouse date: january 27, 2014.Manufacturing site is (b)(4) and supplied by (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Subject device has been received and an investigation summary was performed.The investigation of the complaint articles has shown that: during a transforaminal lumber interbody fusion (tlif) at l4-5, a matrix holding sleeve ¿ long (03.632.036 lot 7506718 mfg 27jan2014) became ¿bent and unusable¿ after the surgeon had difficulty dislodging the holding sleeve from the final screw.The procedure was able to be successfully completed without surgical delay or patient harm.Additionally prior to the procedure the scrub technician noted that the threaded tip of a separate holding sleeve (03.632.036 lot 7506718 mfg 27jan2014) was ¿disconnecting¿; the device was not utilized intraoperatively.The returned instruments were examined and the complaint condition was able to be confirmed in each instance as the distal-most threads of the threaded tips were intact but peeling.No definitive root cause was able to be determined; the failure mode is consistent with the application of an off-axis load while engaging a screw.This investigation summary-was approved.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that one of the matrix long holding sleeves has a thread in the tip of the driver that is disconnecting.The scrub tech noticed the issue on (b)(6) 2016 while setting up for the case.She set the sleeve down on the back table and a backup driver was used for the remainder of the case.During the procedure of a transforaminal lumbar interbody fusion (tlif) at l4-5, the top thread on the backup matrix long holding sleeves got bent and unusable.While dislodging the backup holding sleeve from the last screw, the surgeon had difficulty.He was rocking the instrument back and forth and with a little extra effort it came out of the screw head.The screw was seated in its final place.The instrument was removed from the field.Reportedly, there was no patient harm or surgical delay.The procedure was completed successfully.This complaint involves two (2) devices.This report is 1 of 2 for (b)(4).

• Brand Name: HOLDING SLEEVE-LONG FOR MATRIX
• Type of Device: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5470949
• MDR Text Key: 39746299
• Report Number: 1719045-2016-10177
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2016

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 Catalogue Number: 03.632.036
• Device Lot Number: 7506718
• Other Device ID Number: (01)10705034718941(10)7506718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/25/2016
• Initial Date FDA Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1