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 Known Impact Or Consequence To Patient (2692)
Date of Event	12/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is not available for reporting.Additional device product codes: mnh, mni, kwq, kwp.Device broke intra-operatively and was not fully implanted or explanted.Complainant part is not expected to be returned for manufacturer review/investigation, as part was discarded by the facility.(b)(6).Device history record (dhr) review request: part # 04.632.750, lot # 9882155: manufacture site: (b)(4), manufacture date: 18-aug-2015.No non conformance reports (ncrs) 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 reports an event in (b)(6) as follows: during an initial degenerative lumbar posterior fusion on (b)(6) 2016, the head of a 7.0 mm titanium matrix polyaxial screw 50 mm thread length came off of the shaft of the screw and fell into the patient.The fragment was retrieved.The procedure was completed using a same/like product.Surgical delay and patient outcome is unknown.Concomitant devices reported: unknown instrument.This is report 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: 6329724
• Report Number: 2530088-2017-10040
• Device Sequence Number: 635662
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/19/2017

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: 04.632.750
• Device Lot Number: 9882155
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2017
• Initial Report FDA Received Date: 02/14/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ONE (1) UNKNOWN INSTRUMENT