MAUDE Adverse Event Report: SYNTHES MONUMENT TAP/REAMER FOR TROCHANTERIC FIXATION NAIL SCREW; TAP, BONE

Catalog Number	357.430
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient¿s gender and weight is unknown.Device is an instrument and is not implanted/explanted.Telephone number: (b)(6).A device history record (dhr) review was performed for lot # pe01939: release to warehouse date: 17 oct 2013, expiration date: na, supplier: precision edge surgical: no non conformance reports (ncrs) 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 device has been received and the product evaluation is in progress.No conclusion can be drawn.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 during hip nailing titanium trochanteric fixation nail (tfn) surgery on (b)(6) 2017, the set screw was too deep in the nail therefore the femoral neck screw could not pass through the hole.So surgeon tried to pass it with the tap.The tap broke intra-operatively.The surgeon removed the neck screw and used another one, the nail is still in the patient.The surgery was prolonged about 45 minutes.Patient condition after the surgery was stable.There was no patient harm and the surgery was successfully completed.This report is for one (1) tap/reamer for trochanteric fixation nail screw.This is report 2 of 3 for complaint (b)(4).
Additional Manufacturer Narrative
A product development investigation was performed for the subject device: a visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed at cq for the returned devices as part of this investigation.No product design issues or discrepancies were observed.Part# 357.430 tap/reamer f/tfn fem neck screw.The t-handle has sheared off the shaft at the circumferential laser weld location.Drawing were reviewed during this investigation.No product design issues or discrepancies were observed.Unable to determine a root cause as the nail was not returned to cq for evaluation.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 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
All broken off pieces from the tap were removed from the patient.It was possible to insert the second blade into the nail with the too long set screw.

• Brand Name: TAP/REAMER FOR TROCHANTERIC FIXATION NAIL SCREW
• Common Device Name: TAP, BONE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6656964
• Report Number: 1719045-2017-10585
• Device Sequence Number: 1723607
• Product Code: HWX
• UDI-Device Identifier: 07611819457102
• UDI-Public: (01)07611819457102(10)PE01939
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2017

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: 357.430
• Device Lot Number: PE01939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: Not provided; 07/10/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 06/27/2017; 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR