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

Catalog Number 261221

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Type  Injury  

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 physician reported dural injury while using the perforator in a craniotomy procedure.The injury required hemostat and dural repair.The procedure was completed with the reported product.The event led to 30 minutes of surgical delay.The drill driver was stryker.The physician states there is a possibility of disengagement failure.

Event Description

N/a.

Manufacturer Narrative

(b)(4).Perforator 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.

Manufacturer Narrative

Unique device identifier: (b)(4).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.Failure analysis- the perforator unit was inspected using the unaided eye: organic matter, and a worn eto label were observed.The returned unit was found to work as intended, and met all 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.

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: 10399948
• MDR Text Key: 202735481
• Report Number: 3014334038-2020-00021
• 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,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• 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: J61D59
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STRYKER DRILL DRIVER; STRYKER DRILL DRIVER