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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE/SCREW EXTRACTOR ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE/SCREW EXTRACTOR ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 03.037.030
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  malfunction  
Manufacturer Narrative
Only event year is known. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a synthes employee. Product code 03. 037. 030. Lot number l235284. Manufacturing site: (b)(4). Release to warehouse date: february 23, 2017. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. The device was not returned. A photo-investigation was performed based on all the images. Upon inspecting all the photos provided, the tip of screw/blade extractor was observed to be broken. The root cause of the broken tip cannot be determined based on the available photos. As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed. The complaint condition can be confirmed during photo investigation. During the investigation, no product design issues or discrepancies were observed. No manufacturing issues were noted during investigation. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Therefore, it has been determined that no corrective and/or preventive action is proposed. 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, during a tfna removal and total hip arthroplasty the screw/blade extractor was discovered to be damaged and unusable. The surgeon used knocker forceps to remove the implant. There was no surgical delay. There were no reported complications. This report involves one (1) helical blade/screw extractor. This is report 1 of 1 for (b)(4).
 
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Brand NameHELICAL BLADE/SCREW EXTRACTOR
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 HAEGENDORF GMBH-CN
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11950563
MDR Text Key254648768
Report Number2939274-2021-02796
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.037.030
Device Catalogue Number03.037.030
Device Lot NumberL235284
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 Received05/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/23/2017
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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