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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 AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE INSERTER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 03.037.024
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
This complaint is confirmed as the device was received damaged. The user is reported to have damaged the complaint device. There was no indication that a design or manufacturing issue contributed to the complaint. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Device history lot: part number: 03. 037. 024, lot number: t145415, manufacturing site: (b)(4), release to warehouse date: 15-mar-2017. A review of the device history records was performed for the finished device lot number, and no non-conformances were identified. Device history batch: null. Device history review: null. 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 an unknown date, during hip surgery, the surgeon had a helical blade stuck in a nail and had to damage instruments to get it out. There was a surgical delay of forty-five (45) minutes. The procedure was successfully completed. Patient status is unknown. Concomitant devices reported: helical blade (part # unknown, lot # unknown, quantity 1), helical blade inserter (part # 03. 037. 024, lot # t145415, quantity 1), helical blade/screw coupling screw (part # 03. 037. 026, lot # l234221, quantity 1), 130 degree aiming arm (part # 03. 037. 013, lot #l282383, quantity 1), blade/screw guide sleeve (part # 03. 037. 017, lot # l274027, quantity 1). This report is for one (1) helical blade inserter. This is report 3 of 3 for (b)(4).
 
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Brand NameHELICAL BLADE INSERTER
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key11344487
MDR Text Key232573482
Report Number2939274-2021-00946
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.037.024
Device Catalogue Number03.037.024
Device Lot NumberT145415
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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