MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR 9MM; DRILLS, BURRS, TREPHINES & ACC.

Catalog Number 26-1223

Device Problem Failure to Auto Stop (2938)

Patient Problem No Information (3190)

Event Date 08/29/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Perforator did not stop after perforation.Surgeon stopped use, used a competitor product to continue.No delays.

Manufacturer Narrative

Additional info: device available for evaluation?, date received by mfr, type of reports, if follow-up, what type?, device evaluated by mfr?, additional mfr narrative.Device was returned for evaluation.A follow up report will be filed upon completion of the investigation.

Manufacturer Narrative

Upon completion of the investigation it was noted that the customer's complaint was not verified.The customers¿ perforator met functional test acceptance requirements; proper engagement and disengagement was achieved with every drill hole, and there was no erratic or poor cutting action.The device history records (dhr's) for this perforator were not reviewed because the lot number was not verified.The eto label which contains the lot number was removed from the molded sleeve.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 9MM
• 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: 5955809
• MDR Text Key: 55001364
• Report Number: 1226348-2016-10664
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 26-1223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 09/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/22/2016; 11/03/2016
• 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
• Patient Age: 73 YR
• Patient Weight: 60