MAUDE Adverse Event Report: SYNTHES ELMIRA 11.0MM TI HELICAL BLADE 95MM; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 456.304

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight was not provided by the reporter.Additional device product code is hwc.Date of implant was reported as an unknown date in 2012.The subject device is not expected to be returned to the synthes manufacturer for evaluation.A device history record review was performed for the subject device lot.The review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 11.0mm ti helical blade 95mm non-sterile 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 report (ncr) noted, this ncr was for painted ends on the raw material bars.The paint msds were supplied but 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a trochanteric fixation nail, helical blade, and locking screw implanted on an unknown date in 2012 were removed on (b)(6) 2016 due to necrosis of the patient's femoral head.The explanted devices were successfully removed with no additional medical intervention required.There were no surgical complications.Reportedly the nail was removed with the aid of an extraction hook.The patient status at the end of surgery was reported as "normal".This report is 2 of 3 for (b)(4).

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.

• Brand Name: 11.0MM TI HELICAL BLADE 95MM
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5410037
• MDR Text Key: 37456400
• Report Number: 3003506883-2016-10021
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK011857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 456.304
• Device Lot Number: 6720863
• Other Device ID Number: (01)10886982226693(10)6720863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2016
• Initial Date FDA Received: 02/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 39