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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES ELMIRA 11.0MM TI HELICAL BLADE 105MM-STERILE ROD, FIXATION, INTRAMEDULLARY

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SYNTHES ELMIRA 11.0MM TI HELICAL BLADE 105MM-STERILE ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 456.306S
Device Problems Component Missing (2306); Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/14/2016
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Patient initials are (b)(6). Patient information was not available for reporting. Additional device product code is hwc. (b)(4). As reported, the device was missing from its packaging and was not able to be implanted. The complaint device is not expected to be returned to the synthes manufacturer for evaluation. Evaluation of the product itself is not relevant to the complaint issue. As reported, only the empty sterile packaging was found. A device history record review was performed for the subject device lot. 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. This order met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. Product manufacture date: january 12, 2016. Part expiry date: november 30, 2024. The investigation could not be completed; no conclusion could be drawn. 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 during an open reduction internal fixation procedure to treat a hip fracture, it was discovered that the helical blade was missing from its sterile packaging. The empty helical blade package was included in the trochanteric fixation nail system tray. An additional device was not readily available to complete the procedure and there was a 50 minute surgical delay due to the time it took to get another sterile helical blade. The procedure was completed and the patient's condition was reportedly stable. This report is 1 of 1 for (b)(4).
 
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Brand Name11.0MM TI HELICAL BLADE 105MM-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
terry callahan
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5841787
MDR Text Key51001635
Report Number3003506883-2016-10130
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
Report Date 07/14/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number456.306S
Device Lot Number9976415
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 Received07/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/12/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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