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

Catalog Number 261221

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 07/04/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A physician reported the portion of the sleeve of a perforator (id 261221) cracked during surgery.It occurred when the third burr hole was drilled.It is unknown if the part fall into the surgical site, however, the cracked part was completely removed.According to information provided, it is unknown the drill used with the perforator.It is also unknown if the drill is electric or pneumatic and if the perforator clicks in place in the drill and if the recommended spring tests were performed between each burr hole.The perforator was used for brain tumorectomy, no significant surgical delay.

Event Description

N/a.

Manufacturer Narrative

The codman perforator (261221) was returned for evaluation.Device history record (dhr) - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis: the perforator unit was inspected using the unaided eye: unit was received disassembled and soiled with organic material.The "ifu" testing procedure was performed with no observed anomalies after sleeving and reassembling the unit as it could not be tested in the received condition.No new parts were needed, unit was reassembled with the parts sent back.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release and the unit was found to perform as intended and fulfilled the acceptance criteria.The complaint could not be verified through failure analysis.Root cause: the root cause is undetermined and was unable to be confirmed in the complaint evaluation.The potential causes of failure include user misuse.

• 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: 17350245
• MDR Text Key: 319709055
• Report Number: 3014334038-2023-00112
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2023
• 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