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

Catalog Number 261221

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Injury (2348)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

Unique device identifier (udi): (b)(4).The perforator was not returned for evaluation (per customer, product not available) 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.

Event Description

A physician reported that on (b)(6) 2020 the perforator was used on a (b)(6)-year-old male patient with moyamoya disease.The perforator failed to disengage causing a dura mater injury that was treated with duragen.No information regarding surgical delay was provided.No further information was provided by the hospital.

Manufacturer Narrative

Updated fields:  d4, d9, g1, g3, g6, h2, h3, h4, h6, h10.The perforator was returned for evaluation.Device history record (dhr) - there is no indication that the production process may have contributed to this complaint.Failure analysis - the perforator unit was inspected using the unaided eye.Unit had damaged/illegible "eo" label, no additional anomalies.The ifu testing procedure was performed with 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 complaint could not be verified through failure analysis.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: 10949940
• MDR Text Key: 220687732
• Report Number: 3014334038-2020-00115
• 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: 04/22/2021

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
• Device Lot Number: J7045Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 03/22/2021
• Supplement Dates FDA Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRIMADO DRILL-ROTATION NUMBER 80000
• Patient Age: 40 YR