MAUDE Adverse Event Report: SYNTHES BRANDYWINE 6.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number	04.632.640
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional device product codes are mnh, mni, kwq, and kwp.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.The subject device is not expected to be returned to the synthes manufacturer for evaluation.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for complaint device lot number.Manufacturing location: (b)(4).Date of manufacture: jan 15, 2016.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 complaint device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from canada reported the following event: it was reported that synthes received a report from the (b)(6).(b)(4) reported that the matrix screw wheel head part came detached in the patient.The screw was removed and replaced with another one.No further information is available for reporting.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: updated information for complaint description.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.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 or Problem Description
Update 06apr2017: follow up information received on april 3, 2017 from the sales consultant.Per the sales consultant, the head of the matrix polyaxial screw came off of the shaft of the screw during surgery on (b)(6) 2017 and fell into the patient.The fragment was retrieved and the surgeon used another screw.It was also reported that, although the screw head came off of the shaft during surgery, the screw was received in one piece (it was clarified that the hospital had put it back together and stated that the screw is meant to be taken apart with an instrument).The patient was not adversely affected and there was no reported delay in the procedure.No further information is available.
Additional Manufacturer Narrative
Additional narrative: subject device has been received and a product investigation was conducted: the following complaint device(s) was received by customer quality (cq): one 6.0mm ti matrix polyaxial screw 40mm thread length (part number: 04.632.640, lot number: 9984194, mfg.Date: 15jan2016).The part(s) was received with the following complaint description: ¿the head of the matrix polyaxial screw came off the shaft of the screw during surgery on (b)(6) 2017 and fell into the patient.The fragment was retrieved and the surgeon used another screw.The patient was not adversely affected and there was no reported delay in the procedure.¿ the matrix polyaxial screw (04.632.645) is utilized in matrix and matrix 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.The returned 6.0mm matrix polyaxial screw was examined and the complaint condition could be confirmed as the screw was easily disassembled (polyaxial head separated from the screw body).Minor wear was noted on the screw body consistent with implantation.Replication of the complaint condition is not applicable as the screw head is already damaged.A visual inspection and device history review were performed as part of this investigation, during the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.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.

• Brand Name: 6.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 6460848
• Report Number: 2530088-2017-10085
• Device Sequence Number: 608485
• Product Code: NKB
• UDI-Device Identifier: 10705034745527
• UDI-Public: (01)10705034745527(10)9984194
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 04.632.640
• Device Lot Number: 9984194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/20/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 04/24/2017; 05/09/2017
• Patient Sequence Number: 1