MAUDE Adverse Event Report: SYNTHES MONUMENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS; GUIDE

Catalog Number	357.411
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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) reported the following: it was reported that the patient underwent an insertion of a helical blade during a trochanteric fixation nail (tfn) procedure on (b)(6) 2017 to treat a proximal femur fracture.During the procedure the helical insertion coupling did not align properly making it hard to insert the blade correctly.There was a ten (10) minute delay related to this event.No information available on whether the procedure was completed.No harm was reported to the patient.No information available on patient outcome.Concomitant device reported: helical blade insertion screw (part 357.369, lot 6581164, quantity 1); compression nut (part 357.371, lot 6599561, quantity 1); helical blade coupling screw (unknown part and lot numbers, quantity 1).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Part 357.411, supplier lot 6605563: release to warehouse date: june 16, 2011.Supplier: (b)(4).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 this product that would contribute to this complaint condition.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
The initial complaint was reviewed and found not reportable.The information in this complaint record reasonably suggests that there is no allegation of a complaint against this device and there is no reported malfunction or adverse event caused or contributed to with this device.The device functioned as intended.Should further information become available this determination will be reviewed.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
The initial complaint was reviewed and found not reportable.The information in this complaint record reasonably suggests that there is no allegation of a complaint against this device and there is no reported malfunction or adverse event caused or contributed to with this device.The device functioned as intended.Should further information become available this determination will be reviewed.

• Brand Name: INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6696460
• Report Number: 1719045-2017-10641
• Device Sequence Number: 998740
• Product Code: FZX
• UDI-Device Identifier: 10886982196347
• UDI-Public: (01)10886982196347(10)6605563
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 06/29/2017

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: 357.411
• Device Lot Number: 6605563
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 07/10/2017; 07/20/2017
• Initial Report FDA Received Date: 07/10/2017
• Supplement Report FDA Received Date: 07/12/2017; 07/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1 PART 357.369, LOT 6581164, INSERTION SCREW.; 1 PART 357.371, LOT 6599561, COMPRESSION NUT.; 1 UNKNOWN COUPLING SCREW.