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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES ELMIRA 11.0MM TI HELICAL BLADE 85MM-STERILE ROD,FIXATION,INTRAMEDULLARY

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SYNTHES ELMIRA 11.0MM TI HELICAL BLADE 85MM-STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 456.302S
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Additional device product code is hwc. (b)(4). Therapy date: unknown date in (b)(6) 2015. The subject device is not expected to be returned to the synthes manufacturer for evaluation. (b)(4). The investigation could not be completed; no conclusion could be drawn, as no product was received. A device history record review was performed for the subject device lot. Manufacturer: synthes (b)(4). Date of manufacture: mar 16, 2015. Expiration date: feb 28, 2024. The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. No non-conformances were generated during the production of the subject device. 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 on (b)(6) 2016 revision surgery was performed due to helical blade superior cut out. On an unknown date in (b)(6) 2015, the patient with a history of parkinson's disease underwent surgery for the implantation of a trochanteric fixation nail for a left femur fracture. On an unknown date, it was discovered via x-ray that there was superior cut out of the helical blade. It is unknown if the patient was complaining of pain. On (b)(6) 2016, the patient underwent revision surgery for the removal of the helical blade, trochanteric fixation nail and a 5. 0mm screw. All devices were found to be intact and the patient was not replaced with new hardware. The surgery was successfully completed without delay and the patient was reported as stable. Concomitant medical products: 10mm/130 deg ti cann troch fixation nail 170mm-sterile (part #456. 315s, lot #7874458, quantity 1); screw (partial part # 458. 9xx, lot # unknown, quantity 1). This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
Device was used for treatment, no diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Concomitant device: 10mm/130 deg ti cann troch fixation nail 170mm-sterile (part #456. 315s, lot #7874458, quantity 1), screw (partial part # 459. 9xx, lot # unknown, quantity 1).
 
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Brand Name11.0MM TI HELICAL BLADE 85MM-STERILE
Type of DeviceROD,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
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6127754
MDR Text Key60903910
Report Number3003506883-2016-10191
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011857
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number456.302S
Device Lot Number7938664
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/16/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/25/2016 Patient Sequence Number: 1
Treatment
456.315S, LOT 7874458, 10MM TI CAN TRO FIX NAIL; UNKNOWN SCREW
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