PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE 399.36

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-08-24 for PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE 399.36 manufactured by Synthes (usa).

Event Text Entries

[52858201] Device was used for treatment, not diagnosis. (b)(4). Device is an instrument and is not implanted/explanted. The subject device is not expected to be returned to the synthes manufacturer for evaluation. Without a lot number the device history records review could not be completed. 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.
Patient Sequence No: 1, Text Type: N, H10


[52858202] It was reported that during a procedure to repair a fractured distal clavicle acromioclavicular (ac) joint on (b)(6) 2016, while inserting a 3. 5mm locking compression plate (lcp) plate, the handle of a 6mm periosteal elevator broke apart in the surgeon's hand, cutting the surgeon's glove. The handle of the device broke into two pieces; approximately 25 percent of the handle was still attached to the device and approximately 75 percent broke off. There was a one (1) minute delay while the surgeon re-gloved and obtained another device. The surgery was successfully completed with an alternate instrument with no harm to the patient or the surgeon. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2520274-2016-14333
MDR Report Key5899882
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2016-08-24
Date of Report2016-08-09
Date of Event2016-08-09
Date Mfgr Received2016-08-09
Date Added to Maude2016-08-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTERRY CALLAHAN
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6107195000
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE
Generic NameELEVATOR
Product CodeHTE
Date Received2016-08-24
Catalog Number399.36
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSYNTHES (USA)
Manufacturer Address1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380


Patients

Patient NumberTreatmentOutcomeDate
10 2016-08-24

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