MAUDE Adverse Event Report: INTEGRA YORK, PA INC. LEKSELL RONG 9 SLIGHT-CVD 8MM; CARDIOVASCULAR BONE

Catalog Number 230261

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

On 6/13/16 integra investigation completed.Manufacture date unknown.Method: failure analysis, device history evaluation.Results: failure analysis - leksell rongeur returned in used condition, showing minimal wear and broken at the boxlock, upon visually inspecting the rongeur, it is noticed that there is blackening at the boxlock were broken.Without knowing how the rongeur was handled and maintained, the cause is undetermined.This type of damage to the instrument is usually the result from improper usage.The complaint report is confirmed.Device history review - dhr review.Nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report / nonconforming material report history: variance authorization / deviation history: none.Engineering change order/manufacturing change order history: none.Corrective action preventive action history: none.Health hazard evaluation history: none.Conclusion: the root cause has not been identified as a workmanship or material deficiency.

Event Description

Customer initially reports device broke during a case.On 6/3/16 customer reports that doctor was performing a total knee when a jaw broke off and fell onto the surgical drape.No harm to patient.

• Brand Name: LEKSELL RONG 9 SLIGHT-CVD 8MM
• Type of Device: CARDIOVASCULAR BONE
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5741290
• MDR Text Key: 47916540
• Report Number: 2523190-2016-00095
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 230261
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1