MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACC.

Catalog Number 26-1221

Device Problem Failure to Auto Stop (2938)

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

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts are being made to obtain additional information.Upon receipt of new relevant information, a follow-up report will be submitted.

Event Description

As reported by the affiliate, a perforator failed to disengage, plunging further than normal but there was no reports of patient injury.The surgeon noticed the malfunction and pulled back before injury occurred to the patient.The perforator plunged through the dura and inner table.The drill was at 90.There was no inner rim of bone.The surgeon felt a sucking of the drill and pulled back.The underlying brain was not injured.The surgeon stopped using the perforator.It did not cause a delay of more than 30 min and placed a rural gray at the end.The patient was young with good bone quality and dura quality.There was no raised icp.The patient had normal bone thickness.The device was not re-processed.

Manufacturer Narrative

Udi: (b)(4).Sample was received for evaluation.The sample was visually inspected, no anomalies found.The perforator was then functionally tested.A series of holes with drilled without issue.The device performed as intended.A review of manufacturing records found no anomalies during the manufacturing process.Based on the results of the investigation, the reported issue could not be confirmed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8174130
• MDR Text Key: 131796539
• Report Number: 1226348-2018-10892
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 26-1221
• Device Lot Number: J0737Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Date Manufacturer Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1