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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. AM SURGICAL CE-AM SURG BLADE SINGLE PK STERL SMALL JOINT INSTRUMENT

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WRIGHT MEDICAL TECHNOLOGY, INC. AM SURGICAL CE-AM SURG BLADE SINGLE PK STERL SMALL JOINT INSTRUMENT Back to Search Results
Catalog Number AM96BLD1
Device Problems Break; Tip
Event Date 03/23/2015
Event Type  Injury  
Event Description

Allegedly, patient underwent endoscopic gastric release. The tip of the blade broke off, the surgeon had to spend time searching for tip to retrieve it. There was tissue damage when the surgeon was trying to locate and remove the broken blade tip. Issue was resolved by: fluoroscopy utilized to locate blade; extended surgical time. Sales rep not present during procedure. Surgery time extended greater than 30 minutes. Back-up device available. Implantation site/procedure: gastroc, endoscopic gastroc recession with am surgical. How was issue resolved: the broken piece of blade was finally retrieved. Sales rep not present during procedure. Back-up device not available.

 
Manufacturer Narrative

Investigation not complete. Product has not been returned yet. Trends will be evaluated. This report will be updated when the investigation is complete.

 
Manufacturer Narrative

Sem analysis showed that the weld looked porous in some areas. A review of the device to check for low spots in the tube was conducted as well. This review showed no low spots which could have interfered with the weld. Another instrument from the same lot was reviewed utilizing sem analysis and a contour tracer. There were no low spots which could have interfered with the weld on this instrument either. Based on analysis, a definitive root cause could not be determined.

 
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Brand NameAM SURGICAL CE-AM SURG BLADE SINGLE PK STERL
Type of DeviceSMALL JOINT INSTRUMENT
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer Contact
1023 cherry road
memphis , TN 38117
901867-414
MDR Report Key4704458
Report Number1043534-2015-00022
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type Distributor,COMPANY REPRESENTATIVE,DIS
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/17/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/17/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue NumberAM96BLD1
Device LOT Number1549047
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2015
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 04/17/2015 Patient Sequence Number: 1
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