MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISP PERFORATOR 11MM; DRILLS, BURRS, TREPHINES & ACC.

Catalog Number 26-1222

Device Problem Failure to Auto Stop (2938)

Patient Problem Tissue Damage (2104)

Event Date 07/19/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported by rep, a perforator plunged approximately i inch into the dura.Resection of perforator was required as it was stuck in the bone.Injury was not of clinical significance according to doctor as it plunged into tumor requiring resection.

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.No dhr review possible.The complaint stated the perforator plunged into the dura and was stuck in the bone.The perforator had severe damage to the plastic sleeve.The cutting edges were damaged, potentially by dropping the perforator or the like.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 DISP PERFORATOR 11MM
• 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: 6787601
• MDR Text Key: 82462781
• Report Number: 1226348-2017-10563
• 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
• 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

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 26-1222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2017
• 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