MAUDE Adverse Event Report: SYNTHES BRANDYWINE 6.0MM TI MATRIX POLYAXIAL SCREW 45MM THREAD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	04.632.645
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes: mnh, mni, kwq, kwp.Due to intra-operative issues the device was not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Manufacturing site: (b)(4).Manufacturing date: august 02, 2016.No non-conformance reports or scrap were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.The investigation could not be completed; no conclusion could be drawn, as no product was 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
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the head of a polyaxial pedicle screw loosened while inserting during surgery on (b)(6) 2017.The screw was exchanged intra-operatively; there was a three (3) minute surgical delay, but no patient harm was reported.The surgery was completed successfully.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A product evaluation was performed.The investigation of the complaint articles indicates that: it was reported that the head of a polyaxial pedicle screw loosened while inserting during surgery on (b)(6) 2017.The screw has been exchanged intraoperatively.Therefore the surgery was prolonged by 3 minutes, but no patient harm was reported.The surgery was completed successfully.Complaint involves 1 part.The 04.632.645, lot number h159447, pedicscr matrix 5.5 polyaxial ø6 preassm, the implant was returned with the body and collet (polyaxial screw head) detached from the matrix screw head."the head of a polyaxial pedicle screw loosened while inserting during surgery" this condition is confirmed; the most proximal thread of the matrix screw head is stripped.It is likely that the loose implant fell apart during transportation to cq.A visual inspection under 5x magnification, dhr review, and drawing review were performed as part of this investigation.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device already fell apart.The matrix polyaxial screw (04.632.Xxx) is utilized in matrix deformity and matrix degenerative, as part of the posterior pedicle screw and rod fixation system.There are three components to the matrix polyaxial screw, the body, collet, and matrix screw.The body and collet attachment creates the polyaxial screw head.The body and collet (polyaxial screw head) mates with the matrix screw head to create the matrix polyaxial screw.Although a definitive root cause could not be determined, this complaint condition is consistent with off-axis/excessive force used during loading/engaging of the holding sleeve with the matrix polyaxial screw.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.
Additional Manufacturer Narrative
Device available for evaluation: device returned july 4, 2017.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 45MM 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: 6594171
• Report Number: 2530088-2017-10126
• Device Sequence Number: 13648510
• Product Code: NKB
• UDI-Device Identifier: 10705034745534
• UDI-Public: (01)10705034745534(10)H159447
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2017

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 Model Number: 04.632.645
• Device Catalogue Number: 04.632.645
• Device Lot Number: H159447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2017
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: 07/04/2017; 07/24/2017
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 07/06/2017; 07/26/2017
• Patient Sequence Number: 1
• Patient Age: 75 YR