MAUDE Adverse Event Report: SYNTHES USA 7.0MM TI MATRIX SCREW 50MM THREAD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.639.750

Device Problem Material Frayed (1262)

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

Event Date 07/30/2014

Event Type  malfunction  

Event Description

It was reported that a matrix polyaxial unassembled screw was cross-threaded and was off midline which caused it to shear off of two holding sleeves intraoperatively during a l4-l5 posterior spine fusion.As a consequence, it sheared off the two holding sleeves (part # 03.616.043 x 2), as well as the bone screw itself.It was also reported that there were no metal fragments in the patient.The sales consultant stated that the metal of the screw cut the metal of the holding sleeves when the screw sheared.The metal fragments did not become dislodged from the screw or holding sleeve, but the metal is sticking out of the screw and instruments.Another sleeve and screw were available to successfully complete the procedure.It was reported that there was no adverse event to the patient.A two minute delay was reported.This report is 3 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Without a lot number, the device history record review and the investigation could not be completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A pd evaluation was conducted.The report indicates that one 7.0mm ti matrix screw 50mm thread length 04.639.750 (lot unknown) was received.This screw is an implant part of the matrix (degenerative) spine system.This screw is a member of the standard unassembled screws family which includes different lengths.The applicable technique guide (reference #j9699-d) was reviewed.The technique guide illustrates how to properly load and tighten the holding sleeve into the recess of the screw and cautions not to grasp the green knob during screw insertion as this will cause the holding sleeve to disengage from the screw.The complaint received was that the ¿screw was cross-threaded and was off midline which caused it to shear off of two holding sleeves intraoperatively¿ and it was stated that ¿the metal of the screw cut the metal of the holding sleeves when the screw sheared.¿ upon inspection of received screw, the reported condition was confirmed.Most of the first two internal threads of the head are broken off, with a segment of threading unraveling helically from the screw.The remaining of the body is in good conditions.Improper use of the holding sleeve used in conjunction with the mentioned screwdriver with this screw can contribute to the corresponding failure experienced in this complaint.A review of the applicable tabulated screw drawing and related components (04_639_725 revision a and 04_632_725_1 revision c) were performed.This drawings call out the appropriated dimensions, material and finishing processes for a successful screw design.The device design was found to be adequate for its intended use and did not contribute to this complaint condition.In conclusion, the reported condition was confirmed.Given the complaint description, this condition was likely caused by off-axis application of the holding sleeve interfacing with the screw.The design of this device was found to be adequate for its intended use and did not contribute to this complaint.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: 7.0MM TI MATRIX SCREW 50MM THREAD LENGTH
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES USA; 1302 west lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4039156
• MDR Text Key: 4728764
• Report Number: 2520274-2014-13278
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK100952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.639.750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 42 YR