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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK; CERCLAGE FIXATION

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK; CERCLAGE FIXATION Back to Search Results
Model Number 08.501.001.05S
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/16/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information was not provided for reporting.Device malfunctioned intraoperative.Device was not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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.
 
Event Description
It was reported that during an unknown procedure on (b)(6) 2018.The sternal zipfix teeth mechanism didn't catch as intended when tightened.It is unknown if there was a surgical delay.Patient status and surgical outcome were both unknown.This report is for one (1) sternal zipfix with needle sterile / 5 pack.This is report 1 of 1 for (b)(4).
 
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Brand Name
STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK
Type of Device
CERCLAGE FIXATION
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ   2545
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7842265
MDR Text Key119498488
Report Number2939274-2018-53591
Device Sequence Number1
Product Code JDQ
UDI-Device Identifier20887587025985
UDI-Public(01)20887587025985
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110789
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number08.501.001.05S
Device Catalogue Number08.501.001.05S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/16/2018
Initial Date FDA Received09/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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