• 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 8.5MM/2.8MM WIRE SLEEVE MISC ORTHO SURGICAL INSTR

  • 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 8.5MM/2.8MM WIRE SLEEVE MISC ORTHO SURGICAL INSTR Back to Search Results
Model Number 312.08
Device Problem Material Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Reporter is a synthes employee. Part: 312. 08, lot: 3121840, manufacturing site: (b)(4), release to warehouse date: march 26 2009. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified. Visual inspection: the 8. 5mm/2. 8mm wire sleeve was received showing the teeth of the distal tip bent outwards. The tips/edges of the teeth are bent outwards. Due to the deformation, the wire sleeve may not securely sit into bone. Dimensional inspection: dimensional inspection of the distal tip could not be conducted due to post manufacturing damage. Document/specification review: the following drawings, reflecting the manufactured and current revision, were reviewed. 8. 5mm/2. 8mm wire sleeve. During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition. Conclusion: the complaint condition is confirmed for the 8. 5mm/2. 8mm wire sleeve as the tips/edges of the teeth are bent outwards. Due to the deformation, the wire sleeve may not securely sit into bone. No definitive root cause could be determined. It is possible that the wire sleeve encountered unintended/excessive forces, dense bone, and/or rough handling during device use. During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Based on the investigation findings, 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 on an unknown date, a wire sleeve from a headless compression screw loaner set was found to be unfit for surgical use during a routine inspection. There was no patient and procedure impact reported. Upon manufacturer receipt and investigation the device was found to be bend. This complaint involves one (1) 8. 5mm/2. 8mm wire sleeve. This report is 1 of 1 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name8.5MM/2.8MM WIRE SLEEVE
Type of DeviceMISC ORTHO SURGICAL INSTR
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key9158396
MDR Text Key196197906
Report Number2939274-2019-61211
Device Sequence Number1
Product Code LHX
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number312.08
Device Catalogue Number312.08
Device Lot Number3121840
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-