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

Catalog Number 261221

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Brain Injury (2219)

Event Date 05/11/2021

Event Type  Injury  

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 codman disposable perforator failed to disengage during cranial surgery resulting in dura mater damage.The perforator malfunctioned while making the second burr hole at the tent.The procedure was completed with the product.No surgical delay was reported.The manufacturer of the drill used with the perforator was stryker core2 /signature.It is unknown if the drill was electric or pneumatic, it is unknown if the perforator clicked into place in the drill, and it is unknown if the recommended spring tests were being performed between each burr hole.The patient is in follow-up.No further information was provided.

Manufacturer Narrative

The perforator was returned for evaluation.Unique device identification (udi): (b)(4) or (b)(4).Device history record (dhr) - the lot number for the product was not reported, and the lot number could not be read off the returned product.Therefore, a dhr review is not possible.Failure analysis - the perforator unit was inspected using the unaided eye.Unit was lightly soiled and had a worn eo label.No other anomalies were noted.The "ifu" testing was performed with no observed anomalies.The 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 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.

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
• MDR Report Key: 11917960
• MDR Text Key: 256756588
• Report Number: 3014334038-2021-00108
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

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 Catalogue Number: 261221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 06/01/2021
• Supplement Dates Manufacturer Received: 08/13/2021
• Supplement Dates FDA Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRILL - STRYKER CORE2 /SIGNATURE