MAUDE Adverse Event Report: INTEGRA YORK, PA INC. CARB-EDGE FLUSH WIRE CUTTER 7; N/A

Catalog Number 275525

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A customer reported that the jaw of the carb-edge wire (prod id 275515) was broken during an unspecified procedure and the fragments splashed into the patient's body.There was a delay in surgery to find the fragments.All the broken pieces were removed and the surgery went well.The doctors are monitoring the patient's condition because small invisible pieces can remain in the body and cause inflammation or other problems.Additional information has been requested.

Event Description

N/a.

Manufacturer Narrative

Carb-edge wire (prod id 275515) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Manufacturer Narrative

Follow-up report: product id and lot number update.275515 carb-edge d/a wire cutter 81/2 was not returned for evaluation, therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

Manufacturer Narrative

The carb edge flush wire cutter ( 275525) was returned for evaluation: failure analysis & root cause - the reported complaint has been confirmed.The returned 275515 wire cutter was in used condition with the cutting edge broken due to rough handling/environmental damage.No manufacturing, workmanship or material deficiency has been identified.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• Brand Name: CARB-EDGE FLUSH WIRE CUTTER 7
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 11303184
• MDR Text Key: 232419785
• Report Number: 2523190-2021-00018
• Device Sequence Number: 1
• Product Code: HXZ
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 275525
• Device Lot Number: AA1903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 03/09/2021; 04/28/2021; 06/03/2021
• Supplement Dates FDA Received: 03/23/2021; 05/11/2021; 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1