• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PERCUTANEOUS INSERTION HANDLE F/AIMING A GAUGE,DEPTH

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WRIGHTS LANE SYNTHES USA PRODUCTS LLC PERCUTANEOUS INSERTION HANDLE F/AIMING A GAUGE,DEPTH Back to Search Results
Catalog Number 03.113.025
Device Problem Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Reportedly there was no patient involvement. Date of event is unknown. Device is an instrument and is not implanted/explanted. A device history record review was performed for the subject device: part no. : 03. 113. 025; lot no. : l065951; manufacturing location: (b)(4); release to warehouse date: 11. Nov. 2016. No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. A product evaluation was performed for the subject device: dhr review: review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Service & repair evaluation: the customer reported the instrument had an unknown issue. The repair technician reported the screw was missing. Missing parts is the reason for repair. The cause of the issue is unknown. The following parts were replaced: m3. 5 screw. The item was repaired per the inspection sheet, passed synthes final inspection on 9-may-2018 and will be returned to the customer upon completion of the service and repair process. He evaluation was confirmed. The device was deemed serviceable and returned to the customer. No design or manufacturing issues were identified; therefore, it has been determined that no corrective and/or preventative 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
It was reported that during service evaluation, the screw of a percutaneous insertion handle for aiming arm (right) was found missing and might require replacement. There was no patient involvement reported. This is report 1 of 1 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePERCUTANEOUS INSERTION HANDLE F/AIMING A
Type of DeviceGAUGE,DEPTH
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
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7610733
MDR Text Key112185267
Report Number2939274-2018-52527
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
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 05/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.113.025
Device Lot NumberL065951
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/11/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-