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

Model Number 261221

Device Problem Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/05/2022

Event Type  malfunction  

Event Description

A physician reported a disposable perforator (id 261221) was dull.The physician could not drill the bone and felt the perforator was too dull.He had difficulty in perforating during the procedure.Therefore, another product was used to complete the procedure.No patient injury reported, and the event did not led to surgical delay.According to reported information it is unknown the drill manufacturer, or if the perforator clicked in place on the drill.It is also unknown if the recommended spring tests were performed between each burr hole.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The disposable perforator (id 261221) 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 - while the unit was not able to cut the wood, this was determined to be unrelated to the manufacturing process and likely occurred during surgery.The manufacturing lead and machine operators tried to reproduce the rounded cutting edges on a fresh unit and were unsuccessful.The only step in the perforator manufacturing process that could have potentially caused the rounded edges is during deburring, but ¿over deburred¿ units look much different than the unit in this pr.Due to the lack of additional information, and the inability to reproduce the rounded edges failure, root cause cannot be determined.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.A device history record (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 confirm the complaint.Possible root cause per the failure analysis performed is that the drill likely came in contact with a surface other than the patients skull during surgery which caused the drill bit to dull.Additional information received: - did the physician determine the unit was ¿dull¿ on the 1st burr hole? unknown - what other fixtures / instrumentation was being used alongside the perforator (ex.Clamps, retractors, etc.)? unknown - was there any unexpected drilling / nicking of any surface other than the patient¿s skull using the 1st unit? unknown.

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
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15495749
• MDR Text Key: 300876517
• Report Number: 3014334038-2022-00219
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 10381780513599
• UDI-Public: 10381780513599
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

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 Model Number: 261221
• Device Catalogue Number: 261221
• Device Lot Number: 6188474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 09/28/2022
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1