MAUDE Adverse Event Report: SYNTHES ELMIRA TI SPIRAL BLADE 65MM FOR TI RETROGRADE FEMORAL NAILS-EX; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.013.045
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional patient identifier: (b)(6).Patient weight not available for reporting.Date of non-union is not known.Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review was completed.Dhr review for part # 04.013.045 lot # 6806774.Release to warehouse date: 27 october 2011.Manufacturing site: (b)(4).Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of ti spiral blade 65mm for ti retrograde femoral nails-ex product was processed through the normal manufacturing and inspection operations with no rework or non-conformities noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications but there was a non-conformance noted, ncr#1042105.This ncr was for painted colored ends on the raw material bars.The colored ends have no effect as both the leading and remnant ends are removed during normal processing so material was deemed acceptable.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture 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.
Event or Problem Description
It was reported that a patient was returned to the operating room (or) on (b)(6) 2017 for a non-union of a hindfoot fusion that resulted in the removal of one (1) titanium 10 mm hindfoot arthrodesis cannulated nail, one (1) titanium spiral blade, one (1) 6.0 mm locking screw, three (3) 5.0 mm locking screws and one (1) titanium end cap.The surgeon stated that this was not implant related and delayed healing was caused by diabetes.The original nail was implanted on (b)(6) 2015.The nail was removed, the site was bone grafted with patient iliac crest graft and a new hindfoot nail implanted.The procedure was successful and patient was stable.This report is for one (1) spiral blade for retrograde femoral nails-ex.This is report 2 of 5 for (b)(4).

• Brand Name: TI SPIRAL BLADE 65MM FOR TI RETROGRADE FEMORAL NAILS-EX
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6827908
• Report Number: 3003506883-2017-10190
• Device Sequence Number: 44911
• Product Code: HSB
• UDI-Device Identifier: 10886982087447
• UDI-Public: (01)10886982087447(10)6806774
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K033618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/09/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.013.045
• Device Catalogue Number: 04.013.045
• Device Lot Number: 6806774
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 08/29/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention