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

Catalog Number 03.632.036

Device Problems Material Fragmentation (1261); Device Damaged by Another Device (2915)

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

Event Date 11/03/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information was not provided by reporter.(b)(4).Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation.(b)(6).A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

(b)(6) reported the following event: it was reported that during a lumbar fusion procedure, the matrix screwdriver was not properly holding the matrix screw.The matrix screwdriver is composed of a sleeve and shaft and the nurse had loaded the screw into the screwdriver assembly.When the surgeon attempted to insert the screw, it was discovered that the screwdriver assembly was not properly holding the screw due to the fact that the sleeve portion was chipped and worn.The case was successfully completed with another screwdriver without surgical delay or patient harm.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Product investigation summary: the returned instrument was examined and the complaint condition was able to be confirmed as the distal threaded tip of the device was broken and missing a segment.A definitive root cause was unable to be determined; however, the failure mode is consistent with rough handling over the life of the instrument (4+ years).The holding sleeve is used in the matrix spine system for screw insertion with an appropriate driver.The returned instrument was examined and the complaint condition was able to be confirmed as the distal threaded tip of the device was broken and missing a segment (approximately 1.5mm).The relevant drawings for the sleeve were reviewed during the evaluation.A design change was implemented to address the failure mode of the thread tips breaking.The tip geometry on the inner sleeve was changed to a more constant outer diameter and the material of the outer sleeve changed from radel plastic to anodized titanium.The returned instrument was manufactured prior to the application of these changes as it was manufactured in march, 2011.Device 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 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: 5237927
• MDR Text Key: 31678300
• Report Number: 1719045-2015-10755
• 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,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2015

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 Catalogue Number: 03.632.036
• Device Lot Number: 6508176
• Other Device ID Number: (01)10705034718941(10)6508176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 11/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2011
• 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