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U.S. Department of Health and Human Services

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

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Device Problem Unintended Movement (3026)
Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative
Patient weight is not provided for reporting. Date of postoperative blade cut out is unknown. This report is for one (1) unknown proximal spiral blade. Part and lot numbers are unknown. Without the specific part and lot number, the udi is not available. Implanted in (b)(6) 2017; exact date is unknown. Complainant device is not expected to be returned for manufacturer review/investigation. The (510k#): unknown. 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. 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 report that the patient had original surgery in (b)(6) 2017 for treatment of a humeral fracture. Patient was implanted with one (1) ex humeral nail, one (1) proximal spiral blade, two (2) distal locking screws and one (1) end cap. On an unknown date post-operative, patient presented with a non-union. Also, the nail and blade implant had cut out thru the humerus head bone. On (b)(6) 2017, surgeon removed all implants and revised the patient to a total shoulder replacement. It was reported that no fragments were generated during implant removal. All implants have been retained by the hospital. Revision surgery was completed successfully with no time delay. Patient is reported in stable condition. Concomitant devices reported: distal locking screw (part # unknown, lot # unknown, quantity 2), end cap (part # unknown, lot # unknown, quantity 1), expert humeral nail (part # unknown, lot # unknown, quantity 1). This report is for one (1) unknown proximal spiral blade. This is report 1 of 1 for complaint (b)(4).
 
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Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7165214
MDR Text Key96407949
Report Number2939274-2018-50082
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received12/06/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/04/2018 Patient Sequence Number: 1
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