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 Tissue Damage (2104)

Event Date 07/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

The cerebral bypass surgery was performed on (b)(6) 2017, and the surgeon used the perforator in question to open the 6 burr holes.It was reported that the perforator¿s automatically disengagement mechanism did not work when the surgeon was opening the 6th burr holes.It caused dura mater injury and brain parenchymal damage (about 1 cm).After that, the surgery was completed without any further trouble.The patient¿s condition was stable under ct-scan postoperatively because there was no damage of blood vessel.The patient is (b)(6), male, and the thickness of skull is 5 mm.The surgeon commented that s/he felt some discomfort when opening the 5th burr hole although the perforator in question could be used properly so far.The surgeon also commented that s/he kept the rotation speed below 800 rpm when using perforator regularly.The drill system was aesculap product, (part number is unknown).No further information was provided by hospital.

Manufacturer Narrative

Upon completion of the investigation it was noted that the evaluation performed by r&d revealed: lot number: unknown.No product label attached to returned perforator.No lot number recorded on the complaint form.The complaint stated the perforator failed to disengage during drilling of the 6th burr hole.The perforator had severe damage to the plastic sleeve including a missing piece of the sleeve.However, the drill was able to be functionally tested.Drill was functionally tested 10x.Drill performance was acceptable all 10x.Drill performance was not found defective.No cause could be found for the complaint.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• 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: 6750688
• MDR Text Key: 81289703
• Report Number: 1226348-2017-10522
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2017
• Initial Date FDA Received: 07/28/2017
• Supplement Dates Manufacturer Received: 08/22/2017
• Supplement Dates FDA Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR