MAUDE Adverse Event Report: INTEGRA YORK, PA INC. CARB-BITE COOLEY-BAUM WIRE TWIST 8; PFM02

Catalog Number 121265

Device Problems Break (1069); Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Customer initially reports carb bite insert fractured off during routine use.On 6/24/15 customer reports these two devices broke on two separate cases and he has no information regarding date, patient identification etc.He is making a general complaint that the device broke when tightening chest wires after open heart surgery.Part was retrieved immediately and easily, in each case, from outside the chest cavity and was matched exactly to devices.No harm to patients.

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported information.

Manufacturer Narrative

On 07/16/2015 integra investigation completed.Method: failure analysis - returned instrument/product condition.There were two needle holders in used condition, not showing any unusual markings.The returned needle holders showing wear, staining/discoloration, scratches and broken inserts.Upon visually inspecting the needle holders, it is noticed that there is staining and discoloration within the handle and insert area.It appears the damage to the insert started out as a fracture leading to the breakage.This type of damage is usually the result from improper processing.Device history evaluation - dhr review was completed with all history available.Nonconforming product report/nonconforming material report history: none.Variance authorization/deviation history: none.Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history.Corrective action preventive action history: none.Health hazard evaluation history: none.Conclusion: the complaint report has been confirmed, the root cause has not been identified as a workmanship or material deficiency.

• Brand Name: CARB-BITE COOLEY-BAUM WIRE TWIST 8
• Type of Device: PFM02
• Manufacturer (Section D): INTEGRA YORK, PA INC.; york PA 17402
• Manufacturer Contact: sandra lee ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099366828
• MDR Report Key: 4890848
• MDR Text Key: 6020324
• Report Number: 2523190-2015-00041
• Device Sequence Number: 1
• Product Code: HAO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121265
• Device Lot Number: 100084-1403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1