• 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 ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS PLIERS, SURGICAL

  • 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 ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS PLIERS, SURGICAL Back to Search Results
Model Number 388.50
Device Problems Break (1069); Device Dislodged or Dislocated (2923)
Patient Problem No Patient Involvement (2645)
Event Date 03/21/2018
Event Type  Malfunction  
Manufacturer Narrative

Reportedly there was no patient involvement. Device is an instrument and is not implanted/explanted. Part 388. 50, synthes lot 5214364, 5214365, supplier lot (b)(4): release to warehouse date: april 07, 2006. Supplier: (b)(4). No non-conformance reports (ncrs) were generated during production. Review of the device history record (dhr) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition. A service and repair evaluation was completed: the customer reported the tube was loose and out of the track. The repair technician reported the tube was broken, and the spring and ratchet were worn. Worn out parts is the reason for repair. The cause of the issue is unknown. The following parts were replaced: tube, nut, ratchet, spring (set). The item was repaired and will be returned to the customer upon completion of the service and repair process. The evaluation was confirmed. 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 a rod introduction pliers, for side-opening implants was not functioning properly. The set screw that secure the clip on the tube was not working correctly; it was loose and out of the track. This was identified during routine inspection; there was no patient or procedure involvement. This is report 1 of 1 for (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS
Type of DevicePLIERS, SURGICAL
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
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7468034
MDR Text Key106762421
Report Number2939274-2018-51940
Device Sequence Number1
Product Code HTC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 03/21/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/27/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number388.50
Device Catalogue Number388.50
Device LOT NumberA7PA13
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/26/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/07/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-