MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT VERSAJET HANDPIECE 14MM/45 DEG; LAVAGE, JET

Model Number 50636

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 05/24/2012

Event Type  malfunction  

Event Description

When surgeon depressed foot pedal and the flow of nacl went through the handpiece, the pressure caused the tubing to blow off the end of the handpiece.

Manufacturer Narrative

Although no sample picture provided, no sample available for evaluation, the complaint is confirmed as known, previously investigated issue.For a similar issue the last preventive action was revalidation of the crimpers.Sampled testing for lot release determines an acceptable quality level release to ensure other handpieces from same lot do not have similar issues.Data for lot release indicated that the samples from same lot 27011hk passed the functional test with acceptable pressure in operation.Since no sample was returned, the actual root cause could not be determined.Corrective action for similar issues was revalidation of the crimpers.No further investigation or corrective action will be taken at this time as this failure is being reported on an infrequent basis.Smith & nephew will continue to monitor, track and trend complaints of this nature.Should a significant trend develop, and/or specific safety concerns be identified, further investigation and determination of further corrective actions will be identified and taken at that time.This medical device report (mdr) is being submitted by smith & nephew as a result of a retrospective review of complaints, including adverse events, as part of corrective and remediation actions following the issuance of the 483 issued november 26, 2013 to smith & nephew, inc.Fei no: (b)(4).Smith & nephew is performing a two-year retrospective review of complaint files to re-assess reportability criteria and reporting decisions made for complaints recorded during the time period under review.This complaint has been re-assessed in accordance under the provisions of 21cfr 803.50 and deemed reportable as an mdr.We are submitting one (1) initial, 30 day report, medwatch fda form 3500a, for a purported device malfunction which occurred while using the versajet handpiece.

• Brand Name: VERSAJET HANDPIECE 14MM/45 DEG
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): SMITH & NEPHEW WOUND MANAGEMENT; 970 lake carillon drive; suite 110; st. petersburg FL 33716
• Manufacturer (Section G): SMITH & NEPHEW WOUND MANAGEMENT; 970 lake carillon drive; suite 110; st. petersburg FL 33716
• Manufacturer Contact: terry mcmahon ; 970 lake carillon drive; suite 110; st. petersburg, FL 33716 ; 7273993785
• MDR Report Key: 3769853
• MDR Text Key: 4376072
• Report Number: 3006760724-2014-00302
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: K991383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 50636
• Device Lot Number: 27011HK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/24/2012
• Date Manufacturer Received: 05/24/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1