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

Catalog Number 261221

Device Problem Break (1069)

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

Event Type  malfunction  

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 facility reported the perforator broke during procedure.All parts were recovered, broken pieces did not fall into the surgical site and the procedure was completed with a replacement product.No patient injury and no surgical delay was reported.The perforator was used with a pneumatic anspach emax2plus drill, the perforator click in place with the drill and the spring tests were performed between each burr hole.

Manufacturer Narrative

Unique device identifier (udi) :(b)(4).The perforator was not returned for evaluation and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.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

N/a.

Event Description

N/a.

Manufacturer Narrative

The perforator was returned for evaluation.The perforator unit was inspected using the unaided eye.The unit was returned disassembled with more parts than for one unit, but not enough parts for two entire units.The eo labels were worn and could not be read.Ifu testing was performed.The unit had to be reassembled/re-sleeved as it could not be tested in as-received condition additionally, it was re-sleeved and tested through the failure analysis process in both possible configurations with the parts which were returned.Testing included: applying adequate pressure on the perforator point, ensuring engagement occurs as the hudson end is rotated.When engagement occurs, placing thumb pressure on the perforator point to ensure a smooth, positive spring action.Ensuring the hudson end rotates smoothly within the perforator body when the unit is in the disengaged position.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.

• 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: 10877487
• MDR Text Key: 217458478
• Report Number: 3014334038-2020-00097
• 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: 07/07/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 11/24/2020; 06/22/2021
• Supplement Dates FDA Received: 12/10/2020; 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANSPACH EMAX2PLUS; ANSPACH EMAX2PLUS