• 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 HANDLE WITH QUICK COUPLING, SMALL; TAP,BONE

  • 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 HANDLE WITH QUICK COUPLING, SMALL; TAP,BONE Back to Search Results
Catalog Number 311.43
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The handle with quick coupling, small (p/n 311.43 lot 7363916) was received with a vertical crack on the handle.The crack was across the location of the dowel pin and measured approximately 25.71 mm in length (calipers ca802).The instrument/handle was not separated into two pieces.No other issues were identified with the returned components of the device.A dimensional inspection was not performed during this investigation as the root cause of the device condition has been identified as a device design deficiency, which has subsequently been addressed through capa (b)(4).The reported complaint condition of broken is confirmed for the handle with quick coupling, small (p/n 311.43 lot 7363916) as the instrument was received with a vertical crack on the handle.The crack was across the location of the dowel pin and measured approximately 25.71 mm in length (calipers ca802).A valid design defect was identified as the root cause of the cracked condition.Was launched to address the design defect and was closed on (b)(6) 2017 after effectiveness monitoring of the design changes was deemed effective.No manufacturing issues were identified through the investigation.A corrective and/or preventative action has already been launched and completed to address the design deficiency.See related action.Based upon these findings, no additional 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 # 311.43.Synthes lot number: 7363916.Manufacturing site: synthes (b)(4).Release to warehouse date: 02-may-2013.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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 a routine incoming inspection of loaner set at minor kings mountain, field stock location (fsl), the small handle with quick coupling was broken.There was no known hospital or patient involvement.This report is for one (1) handle with quick coupling, small.This is report 1 of 1 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HANDLE WITH QUICK COUPLING, SMALL
Type of Device
TAP,BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8892894
MDR Text Key154406418
Report Number2939274-2019-59815
Device Sequence Number1
Product Code HWX
UDI-Device Identifier10886982187390
UDI-Public(01)10886982187390
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 07/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number311.43
Device Lot Number7363916
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2019
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/02/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-