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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT-STER ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT-STER ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 456.355S
Device Problem Device Difficult to Maintain (3134)
Patient Problem No Code Available (3191)
Event Date 06/04/2019
Event Type  Injury  
Manufacturer Narrative
Additional pro-code: hwc. Exp dae is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. A review of the device history record has been requested. (b)(4). 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 on (b)(6) 2019, during the trochanteric fixation nail (tfn) left hip the locking mechanism would not engage. The locking mechanism in the tfn nail would not lock. The surgeon stated it would not lock and it felt stripped and the surgery was completed with the nail not being locked. There was no surgical delay. Patient status is unknown. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
 
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Brand Name10MM/130 DEG TI CANN TROCH FIXATION NAIL 340MM/LEFT-STER
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)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8751028
MDR Text Key149759107
Report Number2939274-2019-58960
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K011857
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,Followup,Followup
Report Date 06/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Model Number456.355S
Device Catalogue Number456.355S
Device Lot Number7070973
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/03/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/01/2019 Patient Sequence Number: 1
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