MAUDE Adverse Event Report: SYNTHES BRANDYWINE 4.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.632.440

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.Patient weight reported as approximately (b)(6).Unknown when screw broke postoperatively.(b)(4).Reporter telephone number is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.Manufacturing review was completed; release to warehouse date: 25-mar-2014, expiration date: n/a.Manufactured by synthes (b)(4).No ncrs were generated during production.Review of the device history record(s) showed there were no issues during the manufacture of this product that would contribute to this complaint condition.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows it was reported that during a planned removal of stabilizing pedicle screws l1-l3 on (b)(6) 2016 due to patient request, the surgeon observed that the left side l1 screw was broken.Original implant date was reported as (b)(6) 2015.Only the proximal portion of the screw could be retrieved.The patient had previously complained of pain and irritation prior to the revision surgery, however, the fracture had healed.The surgeon stated the screw had not broken intraoperatively during the removal.The remainder of the implants were removed intact without difficulty.The distal portion of the l1 left side screw remains in patient.No attempt was made to retrieve the broken fragment.Surgery was completed without further complication.No surgical delay was reported.Outcome of procedure was stated as satisfactory.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional product device codes: mnh, mni, kwq, kwp.A product development investigation was performed for the subject device (4.0mm ti matrix polyaxial screw 40mm thread length, part number 04.632.440, lot number 7643523).The subject device was returned with the complaint condition stating that during a hardware removal procedure, at the patient's request, it was discovered that a 4.0mm polyaxial screw was broken.The construct was removed; however the distal portion of the screw was not removed from the vertebral body.The returned 4.0mm matrix polyaxial screw was examined and the complaint condition was able to be confirmed as the screw body was found to be broken with the distal-most 22.4mm missing and not returned.Additional wear consistent with implantation/explantation was noted on the screw body and drive recess.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.Additionally the following concomitant devices were returned without allegation: locking caps (part 09.632.099 lots 7911961, 7919516, 9810599 (x2)), 6.0mm polyaxial screws (part 04.632.635 lots 7976152, 7762788), 4.0mm polyaxial screw (part 04.632.440 lot 7811788), 5.5mm rod (part 04.633.285 lot 8567953), snap-on transconnector (part 04.633.338 lot 7955477).Upon visual inspection there is no evidence that the devices contributed to the complaint condition, and therefore no additional investigation will be performed on these devices.The matrix polyaxial screw (04.632.440) is utilized in matrix deformity and matrix degenerative as part of the posterior pedicle screw and rod fixation system.Polyaxial screws are available in 4.0mm, 5.0mm, 5.5mm, 6.0mm, 7.0mm, 8.0mm and 9.0mm diameters and lengths ranging from 20-100mm.Relevant drawings for the returned screw were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.No definitive root cause was able to be determined with the provided information.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.(b)(6).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: 4.0MM 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5983756
• MDR Text Key: 55826841
• Report Number: 2530088-2016-10274
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K100952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.632.440
• Device Lot Number: 7643523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2016
• Initial Date FDA Received: 09/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention