MAUDE Adverse Event Report: SYNTHES BRANDYWINE 7.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.632.740

Device Problem Fitting Problem (2183)

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

Event Date 03/30/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Original implant surgery date was: (b)(6) 2016.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records was conducted.The report indicates that the: dhr review for part#04.632.740 lot#7937087 releases to warehouse date: 25-feb-2015, manufactured by synthes (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.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 a posterior fusion with matrix pedicle screws and rods at the l4-s1 level, while the surgeon was adjusting the tuliphead portion of the screw with the head turner instrument, the shaft portion of the screw was backing out creating an inability to seat the rod.The screws were removed and different screws were provided to the surgeon to complete the surgery.The procedure was completed successfully with no surgical delay and there was no patient harm.Operative report and x-rays are not available.There was no clinical factors.This complaint involves 2 parts.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that: two matrix polyaxial screws (04.632.740 lots 6986980 mfg 16-jul-2012 and 7937087 mfg 25-feb-2015) would not accept a rod as a result of misaligned collets.The procedure was able to be complete successfully, without surgical delay or patient harm, with immediately available alternate screws.The returned 7.0mm matrix polyaxial screws were examined and the complaint condition was able to be confirmed in each instance as the collets were found to be rotated.The received condition is consistent with the complaint description as the collet rotation would inhibit appropriate rod seating within the polyaxial screw and could potentially lead to a loose construct.No definitive root cause was able to be determined; the failure mode is typically associated with polyaxial head mobilization without the use of the polyaxial head alignment tool (03.632.007) allowing the polyaxial head to rotate irrespective of collet position.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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 POLYAXIAL SCREW 40MM THREAD LENGTH
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5579413
• MDR Text Key: 42764657
• Report Number: 2530088-2016-10106
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.632.740
• Device Lot Number: 7937087
• Other Device ID Number: (01)10705034745664(10)7937087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 36 YR