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

Catalog Number 26-1221

Device Problem Failure to Auto Stop (2938)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

(b)(4).It has been reported that the device will be returned for evaluation.Upon receipt of the device or additional relevant information, a follow-up report will be submitted.

Event Description

It was reported that the perforator did not stop when the dural space appeared and hurt the duramater and produced a hemorrhage.The midas rex was the drill used with the perforator.The drill speed was 70,000rpm.The target site was pericoronal midline over the superior sagittal sinus.The thickness of the bone was 1cm and the bone quality was good.There was no underlying issues causing an increased icp.The perforator was held perpendicular to the bone during use.The perforator has not been re-processed.The sample will be returned for evaluation.

Manufacturer Narrative

Udi: (b)(4).Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies when the device was released.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: CODMAN DISP PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8381531
• MDR Text Key: 137514343
• Report Number: 1226348-2019-10154
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 26-1221
• Device Lot Number: J03Y99
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2019
• Initial Date FDA Received: 03/01/2019
• Supplement Dates Manufacturer Received: 03/19/2019
• Supplement Dates FDA Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other