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

Catalog Number 03.632.036

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2016

Event Type  malfunction  

Manufacturer Narrative

Patient initials: (b)(6).Patient weight is unknown device is an instrument and is not implanted/explanted.Part 03.632.036, lot 7492388: release to warehouse date: january 27, 2014.Supplier: (b)(4).No non-conformance reports 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.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device was used for treatment, not diagnosis.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 during posterior l3-l5 spinal fusion surgery using matrix spine system on (b)(6) 2016, there was an issue with a holding sleeve.When the surgeon was on left side in l5 implanting screw with holding sleeve (long), the retaining sleeve interfaced with screw head and screw was daggling.When surgeon pulled out the screw, screw was found damaged and a thread is hanging off of the screw.A second screw was implanted using the same holding sleeve and the holding sleeve interfaced with screw head and when the surgeon pulled out the screw, screw was found cracked.Then the third screw was implanted using the second holding sleeve and the procedure was completed successfully.There was surgical delay of fifteen (15) minutes.There were no fragments generated and both screws were removed easily.Patient status is reported as stable.Upon investigation after the surgery, it was found that the threads on second sleeve were damaged.Upon visual inspection of returned device by the manufacturer it was noted the first holding sleeve which was used with first and second screws had damaged thread tip.Device will be assessed as part of the complaint and is no longer considered concomitant.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that: it was reported that during an l3-l5 fusion procedure utilized the matrix spine system, the surgeon experienced difficulty inserting a pedicle screw into the left side of the l5 vertebra.Two screws and two holding sleeves were damaged attempting to insert a screw at the location.The procedure was able to be completed successfully after a 15 minute surgical delay.The returned devices were examined and in each instance the complaint conditions were able to be confirmed.Parts 3-4: holding sleeve - long (03.632.036 lots 7492388/6972477) the returned matrix holding sleeves (03.632.036) were examined and the complaint conditions were able to be confirmed in each instance.The threaded tip for lot 7492388 was found to be cracked, but intact, and the threaded tip for lot 6972477 was found to be missing a segment for the distal-most thread (approximately 2.75mm x 1mm x 0.5mm ¿ calipers ca94).No definitive root cause was able to be determined; the failure modes are consistent with the application of an off-axis load while engaging a screw.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: HOLDING SLEEVE-LONG FOR MATRIX
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5924239
• MDR Text Key: 53792293
• Report Number: 1719045-2016-10662
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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,Followup,Followup
• Report Date: 07/26/2016

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: 7492388
• Other Device ID Number: (01)10705034718941(10)7492388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/12/2016
• Initial Date FDA Received: 09/02/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/19/2016; 09/21/2016
• 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
• Patient Age: 47 YR