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

Catalog Number 261221

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2020

Event Type  malfunction  

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 facility reported the perforator did not disengage during surgery.Surgeon states this is the 3rd incident in a month, the other two were not reported because they thought it might have been isolated cases.The procedures were either completed with a new drill bit, or it occurred on the last burr hole so the procedure could continue as usual with a 5-10 minutes surgical delay to switch the drill.No patient injury.

Manufacturer Narrative

Unique device identifier (udi): (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- product was visually inspected; damage to the molded sleeve no label present, rust and organic matter.Ifu testing procedure:the unit could not be tested in the as received condition due to damage on the molded sleeve (non manufacturing related), preventing the hudson-end from spinning freely.The unit was re-sleeved and was found to performed as intended.Functional testing:the unit could not be tested in the as received condition due to damage on the molded sleeve (non-manufacturing related).The unit was re-sleeved, and completed testing (5 holes) and was found to performed as intended.Conclusion - the returned unit was found to work as intended, and met all acceptance criteria.The complaint could not be verified (unconfirmed) through failure analysis.The root cause is undetermined, and the reported complaint was unable to be confirmed in the complaint evaluation.The returned perforator tested within specifications.

Event Description

N/a.

Manufacturer Narrative

Unique device identifier (udi)- (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.

• 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: 10218398
• MDR Text Key: 200772255
• Report Number: 1226348-2020-00327
• 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: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Device Lot Number: J59K06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1