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

Catalog Number	04.632.750
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Patient information not available for reporting.Additional classification codes: mnh, mni, kwo, kwp.Synthes manufacturing location was discovered upon receipt of subject device.Device malfunctioned intra-operatively and was not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4).Device history records review was conducted.The report indicates that the: part# 04.632.750 lot# 9882155, manufacture site: (b)(4), manufacturer date: 18-aug-2015.No ncrs or scrap was generated during production.Review of the device history records ensured that inspection records and certification, confirms that the material, components and final product, as applicable, met inspection records, certification test values and acceptance criteria.This review shows that there were no issues during the manufacture of the 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 or Problem Description
Device report from synthes on an event in (b)(6) as follows: (b)(6) report number: (b)(4) reported that a poly screw 7 mm x 50 mm head broke.Surgeon was able to remove the other part screw and replace with a new screw.The screw is from matrix degen set.There is 1 device in this complaint.This report is 1 of 1 for (b)(4).

• Brand Name: 7.0MM TI MATRIX POLYAXIAL SCREW 50MM 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: 6273075
• Report Number: 2530088-2017-10028
• Device Sequence Number: 11019607
• Product Code: NKB
• UDI-Device Identifier: 10705034745688
• UDI-Public: (01)10705034745688(10)9882155
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 04.632.750
• Device Lot Number: 9882155
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2017
• Initial Report FDA Received Date: 01/24/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention