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

Catalog Number 26-1222

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 09/06/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The rust was found on the tip of the perforator when the surgeon was attaching the drill.The doctor decided to use another one.Therefore this surgery was completed.The surgeon request to investigate what is this dirt is and whether there is any problem this product to use? no further information was provided by hospital.

Manufacturer Narrative

Upon completion of the investigation it was noted that the customer's complaint was verified.Corrosion (rust) was observed on flutes drill body and inner drill.Root cause to the corrosion is unknown however, this most likely occurred out in the field, this however could not be confirmed.All perforators are visually inspected 100% for staining during the in-process assembly as well as a final qc inspection.A review of the device history records (dhr) for this lot (cj018s) show that all test and inspections, including visual inspection, met specification requirements.No corrective actions taken.The device history records (perforator assembly) shows that all tests and inspections, including a visual inspection, met specification requirements.The customer's perforator met functional test acceptance requirements; proper engagement and disengagement was achieved with every drilled hole.There was no erratic or poor cutting action.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.

Event Description

The rust was found on the tip of the perforator when the surgeon was attaching the drill.The doctor decided to use another one.Therefore this surgery was completed.The surgeon request to investigate what is this dirt is and whether there is any problem this product to use? no further information was provided by hospital.

• 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: 5983459
• MDR Text Key: 55821331
• Report Number: 1226348-2016-10688
• 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: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 26-1222
• Device Lot Number: CJ018S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2016
• 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