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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BLD GUIDE SLEEVE FOR TFN APPARATUS, TRACTION, NON-POWERED

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC BLD GUIDE SLEEVE FOR TFN APPARATUS, TRACTION, NON-POWERED Back to Search Results
Model Number 357.369
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2022
Event Type  malfunction  
Event Description
It was reported that on (b)(6), 2022, during a procedure the surgeon inserted the blade/sleeve into the aiming arm and pushed in the buttress/compr-nut f/357. 369 and guide sleeve f/helical blade f/tfn in to the aim-arm f/tfn 130°, which popped out of the aiming arm three(3) times. Another set was opened up and the case was finished with no issues. Procedure was completed successfully with a surgical delay of three(3) minutes. No patient consequences. This report is for one (1) bld guide sleeve for tfn. This is report 3 of 3 for complaint (b)(4).
 
Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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.
 
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Brand NameBLD GUIDE SLEEVE FOR TFN
Type of DeviceAPPARATUS, TRACTION, NON-POWERED
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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13621280
MDR Text Key286884157
Report Number2939274-2022-00706
Device Sequence Number1
Product Code HST
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 Health Professional
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number357.369
Device Catalogue Number357.369
Device Lot Number4571090
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/27/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/28/2022 Patient Sequence Number: 1
Treatment
130 DEG AIM ARM F/TFN; BUTTRESS/COMPRESSION NUT FOR 357.369
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