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

Catalog Number 26-1221

Device Problem Dull, Blunt (2407)

Patient Problem No Information (3190)

Event Date 03/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It has been communicated that the device is not available for evaluation.Without the device, it is not possible for codman to conduct a proper investigation.Since a lot number has been provided a review of the manufacturing records will be reviewed.We anticipate that the evaluation will reveal that the device conformed to specifications prior to release.If anything otherwise is found then a follow up report will be filed.If at some point the device does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.Device not available.

Event Description

It was reported that the surgeon felt the perforator was dull and less sharp when the surgeon drilled the patient¿s skull during the craniotomy surgery on (b)(6) 2017.The reported device was re-sterilized and reused.There was no adverse consequence to the patient and no further information was provided by hospital reported.Per affiliate: the reported perforator was used for a craniotomy for unruptured cerebral aneurysm on (b)(6) 2017.The perforator was used with emax2plus, and total 4 holes were made with the product.When making the 3rd hole, the perforator¿s stopper didn¿t function and the blade contacted to patient¿s dura.Since the adhesion of dura and skull was very tight, the surgeon used craniotorm before performing enough separation of dura, and it was found that the damage led to traumatic subarachnoid hemorrhage.The adverse consequence to the patient might be a short-term memory impairment, a speech impediment, and an epilepsy.The surgeon commented that the blade of perforator felt dull, so he/she might put extra power on the device than usual.Also the surgeon suspects the stopper did not function appropriately by debris or some other reasons.Per affiliate, perforator is not being returned.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; new bedford industrial park; new bedford MA 02745
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6513152
• MDR Text Key: 73513856
• Report Number: 1226348-2017-10276
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Device Lot Number: LJ023S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1