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 10/22/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported by the ous affiliate, 2 perforators did not disengage, resulting in damage to the dura.

Manufacturer Narrative

Device was returned for evaluation.A follow up report will be filed upon completion of the investigation.

Manufacturer Narrative

(b)(4).The device was returned for evaluation.The perforator was visually inspected.No anomalies were found.The device was functionally tested.No issues were noted.The device functioned as intended.A review of manufacturing records found no anomalies during the manufacturing process.Based on the evaluation of the device, the reported issue could not be confirmed.The unit functioned as intended.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.Refer to mdr 1226348-2017-10829 for information regarding the second device associated with this event.

• 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: 7026648
• MDR Text Key: 91902847
• Report Number: 1226348-2017-10830
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 26-1222
• Device Lot Number: HB1457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 11/13/2017
• Supplement Dates Manufacturer Received: 11/20/2017; 03/12/2018
• Supplement Dates FDA Received: 11/20/2017; 03/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2017
• 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