MAUDE Adverse Event Report: SYNTHES MONUMENT TI MATRIXNEURO SCREW SELF-DRILLING 4MM; BONE PLATE

Catalog Number	04.503.104.20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device broke during insertion; device was not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Sterile kit part 145.321s, lot l092044: manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: august 11, 2016.Expiry date: august 01, 2026.Non-sterile screw part 04.503.104.20, lot h110805: manufacturing location: (b)(4).Manufacturing date: may 24, 2016.This complaint is assessed as not related to sterilization.No non-conformance reports 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 condition.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 (b)(4) reports an event in (b)(6) as follows: it was reported that during implantation the head of a screw from a matrix neuro sterile kit broke.The surgery was not prolonged.There was no patient harm and all broken off pieces were removed.There were no adverse consequences for the patient.The surgery was successfully completed.This is report 1 of 1 for com-(b)(4).

• Brand Name: TI MATRIXNEURO SCREW SELF-DRILLING 4MM
• Common Device Name: BONE PLATE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6193085
• Report Number: 1719045-2016-10936
• Device Sequence Number: 976218
• Product Code: JEY
• UDI-Device Identifier: 20887587018345
• UDI-Public: (01)20887587018345(10)H110805
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K042365
• 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
• Report Date (Section B): 11/29/2016

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: 04.503.104.20
• Device Lot Number: H110805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2016
• Initial Report FDA Received Date: 12/21/2016
• Patient Sequence Number: 1