MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CARB-BITE COOLEY-BAUM WIRE TWIST 8; PFM02

Catalog Number 121265

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2021

Event Type  Injury  

Event Description

A facility reported that the carb-bite cooley-baum wire twist 8 ((b)(4)) broke at the tip during spinal surgery.There was a delay in surgery of approximately 30 minutes.The patient returned four (4) days later for an ind procedure to locate the tip.The piece was successfully removed; according to facility, the patient did not incur any complications as a result.It was reported that the patient has fully recovered.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Updated fields:  d4, d9, g3, g6, h2, h3, h6, h10, h11 corrected fields: b1, h1, h6 (clinical code) the reported carb-bite cooley-baum wire twist (121265) has not been returned for evaluation after three (3) good faith attempt efforts (gfes) were made.Lot number information has not been provided; therefore, evaluation of the device history review (dhr) could not be performed.As a result, a definitive root cause could not be determined.It was concluded that the issue of a broken tip may be the result of rough handling or environmental damage.No further investigation is required based on the acceptability of risk and no adverse trends have been identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.If the product is returned at a later date, a follow-up report will be submitted.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

The carb-bite cooley-baum wire twister (121265) was later received for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: visual evaluation noted that the wire twister was in used condition with a portion of the tip's grip broken off.Root cause analysis: the complaint reported by the customer was confirmed.The returned wire twister was received with a portion of the wire grip broken off 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-BITE COOLEY-BAUM WIRE TWIST 8
• Type of Device: PFM02
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13052756
• MDR Text Key: 286889387
• Report Number: 3014334038-2021-00262
• Device Sequence Number: 1
• Product Code: DWS
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2022

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: 121265
• Device Lot Number: AA2004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 05/18/2022; 05/18/2022
• Supplement Dates FDA Received: 01/23/2022; 05/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2020
• 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