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

Catalog Number AM96BLD1

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

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.

• Brand Name: AM SURGICAL CE-AM SURG BLADE SINGLE PK STERL
• Type of Device: SMALL 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 Key: 4704458
• MDR Text Key: 5721307
• Report Number: 1043534-2015-00022
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor,company representative,dis
• Reporter Occupation: Other
• 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 Received: 04/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: AM96BLD1
• Device Lot Number: 1549047
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR