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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE INSERTER ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE INSERTER ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 03.037.024
Device Problem Mechanical Jam (2983)
Patient Problem No Code Available (3191)
Event Date 04/08/2018
Event Type  Injury  
Manufacturer Narrative
Patient information is not available for reporting. Device is an instrument and is not implanted/explanted. (b)(4). The subject device has been received and the product evaluation is in progress. No conclusion can be drawn. A review of the device history records has been requested and is currently pending completion. 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 a procedure on (b)(6) 2018 a spiral blade inserter did not fit properly through the blade insertion sleeve. It's jammed inside the sleeve. The procedure was completed successfully by using a lag screw instead of a blade. There was a surgical delay of ten minutes to complete the procedure. This report is for one (1) helical blade inserter. This is report 1 of 2 for complaint (b)(4).
 
Manufacturer Narrative
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
During manufacturer¿s preliminary analysis of the returned device it was observed that the yellow etching on the helical blade inserter is missing.
 
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Brand NameHELICAL BLADE INSERTER
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES TUTTLINGEN
unter hasslen 5
tuttlingen 78532
GM 78532
Manufacturer Contact
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7472065
MDR Text Key106855905
Report Number2939274-2018-51949
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.037.024
Device Catalogue Number03.037.024
Device Lot NumberT144458
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/20/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/30/2018 Patient Sequence Number: 1
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