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

Catalog Number 261221

Device Problem Failure to Eject (4010)

Patient Problem Injury (2348)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

Udi = (b)(4).Complaint sample 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.

Event Description

A physician reported the codman disposable perforator failed to disengage while making the initial burr-hole for surgery in the left frontal region of the cranium.The drill was caught in bone the first time the device was used in surgery.The physician reported it was difficult to remove the perforator from the bone and the device was caught in bone and required shaving bone around the device to remove the device.As a result, the dura mater was sutured and scarred.The device was changed to a new one and the procedure was completed.A surgical delay in over 30 minutes was observed.

Manufacturer Narrative

The perforator 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.Unique device identifier (udi) : (b)(4).Failure analysis - the perforator unit was inspected using the unaided eye.Organic matter and no "eto" label present were observed.Ifu testing procedure was performed after cleaning the drill and resleeving it.The drill was bound and ifu testing was unable to be completed in the as-received condition of the drill, no observed anomalies.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.In the failure analysis that was performed, the returned unit was found to work as intended, and met all acceptance criteria.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.A dhr review and trending were performed as part of the evaluation.Proper finished goods testing was performed prior to release as indicated in the dhr.Product was received for analysis and the investigation could not confirm the complaint.The risk remains acceptable per the risk analysis.

Event Description

N/a.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10218433
• MDR Text Key: 197159380
• Report Number: 1226348-2020-00337
• Device Sequence Number: 1
• Product Code: HBF
• 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
• Type of Report: Initial,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Device Lot Number: HY4410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 20 YR