MAUDE Adverse Event Report: INTEGRA YORK, PA INC. VARADY PHLEBECTOMY EXTRACTOR,6-3/4,SM HOOK/SPATULA; JARIT

Catalog Number 10310

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation.However, a picture was provided showing the phlebectomy extractor with a broken hook tip.Upon inspection of the picture the hook was missing from the tip.The dhr documentation was reviewed and no anomalies that could be associated with the complaint incident.No service history was available to be reviewed.This complaint has been confirmed as damaged or worn.The root cause has not been identified as a workmanship or material deficiency.

Event Description

The integra sales representative reported on behalf of the customer that on (b)(6) 2018 a 10310 varady phlebectomy extractor, 6-3/4, sm hook/spatula was broken at the tip of the hook.No patient contact, injury, or surgery delay was reported.Additional information was requested but no other clinical information has been provided.

Manufacturer Narrative

The device was returned to the manufacturer for physical evaluation.The failure mode was confirmed.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.The returned microhook spatula showing minimal wear and a broken tip.Without knowing how much pressure was used to the tip when in use, the cause is undetermined.This type of damage is usually the result from improper usage.The complaint report is confirmed; damaged/ worn.The root cause has not been identified as a workmanship or material deficiency.

• Brand Name: VARADY PHLEBECTOMY EXTRACTOR,6-3/4,SM HOOK/SPATULA
• Type of Device: JARIT
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 7484159
• MDR Text Key: 107983077
• Report Number: 2523190-2018-00065
• Device Sequence Number: 1
• Product Code: GAI
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Date Manufacturer Received: 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1