MAUDE Adverse Event Report: RAYNHAM CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS

Model Number 261221

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem Brain Injury (2219)

Event Date 03/14/2022

Event Type  Injury  

Event Description

A physician reported disengagement failure of a perforator during surgery causing dural damage.Dural suture was performed.The perforator was used with elan4 (aesculap).The procedure was completed with a replacement product.The event led to less than 30 minutes surgical delay.It is unknown if the perforator clicked in place with the drill or if the recommended spring tests were performed between each burr hole.

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Lot number provided: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Udi - (b)(4).Manufacturing date is december 17, 2021.Expiration date is november 30, 2026.

Manufacturer Narrative

Updated fields:  d4, d9, g3, g6, h2, h3, h10.Udi #: (b)(4).The disposable perforator (id 261221) was not returned for evaluation (as per customer, product not available) and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue 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.

Event Description

N/a.

Manufacturer Narrative

Perforator was returned for evaluation: failure analysis - the perforator unit was inspected using the unaided eye.Anomalies observed were a heavily soiled perforator with organic matter, showing signs of rust.Ifu testing was performed, and the following was observed; the unit had a frozen inner/outer drill which had to be freed.Once free, the unit performed as intended.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The unit was found to perform as intended and fulfilled the acceptance criteria.The complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was received for analysis and the investigation could not confirm the complaint.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: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13939613
• MDR Text Key: 288118209
• Report Number: 3014334038-2022-00066
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 10381780513599
• UDI-Public: 10381780513599
• Combination Product (y/n): N
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/26/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 261221
• Device Catalogue Number: 261221
• Device Lot Number: 5958506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 03/29/2022
• Supplement Dates Manufacturer Received: 03/30/2022; 04/19/2022; 06/29/2022
• Supplement Dates FDA Received: 04/12/2022; 04/19/2022; 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male