CONTAINER ?1.6 L150 308.206

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2015-02-23 for CONTAINER ?1.6 L150 308.206 manufactured by Synthes Usa.

Event Text Entries

[5516284] Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the blue end caps of the k-wire containers broke after repeated sterilization during the cleaning process. This report is 2 of 6 for com-(b)(4).
Patient Sequence No: 1, Text Type: D, B5


[12792927] Device was used for treatment, not diagnosis. This report is for one unknown k-wire container? 1. 6 l150/unknown lot number. Not implanted/explanted. (b)(6). Device is not distributed in the united states, but is similar to device marketed in the usa. Without a lot number the device history record review and 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


[31216759] An investigation was performed; the investigation of the returned containers for k-wires has confirmed that one or more lips are broken off. The containers are made of polyphenylene sulfone (ppsu) and should resist several thousand sterilization cycles. However, it should be noted that the resistance of ppsu becomes very restricted due to combinations of chemical, thermal and mechanical loads. Thus it is known that contact with some rinse aid can lead to stress cracking. Therefore; the use of a rinse aid, whose compatibility with polyphenylene sulfone is guaranteed by the supplier. As no product fault could be detected, no further action required. 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


[32669914] Subject device has been received and is currently in the evaluation process. 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2520274-2015-11098
MDR Report Key4537110
Report Source01,05,07
Date Received2015-02-23
Date of Report2015-02-09
Date of Event2015-12-15
Date Mfgr Received2015-03-23
Date Added to Maude2015-02-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactLINDA PLEWS
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6107195000
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCONTAINER ?1.6 L150
Generic NameWIRE,FIXATION,INTRAOSSEOUS
Product CodeDZK
Date Received2015-02-23
Returned To Mfg2015-02-19
Catalog Number308.206
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSYNTHES USA
Manufacturer Address1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380


Patients

Patient NumberTreatmentOutcomeDate
10 2015-02-23

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