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

Catalog Number 26-1221

Device Problem Dull, Blunt (2407)

Patient Problem No Information (3190)

Event Date 08/12/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Per rep, verbally, event occurred where it took perforator almost 5 minutes to cut into skull.They used 6-7 different perforators, all were dull.Rep feels delay caused adverse affects to patient.On (b)(6) 2015: per rep, only 2 perforators are being returned.On (b)(6) 2015: per rep, the "dullness issue", "could have caused a delay of up to 30 minutes".Also, 2 drills were used in the incident.On (b)(6) 2015: per rep, the 2 drills mentioned were manufactured by medtronic.The other 5 perforators that were not returned were discarded.

Manufacturer Narrative

Upon completion of the investigation it was noted that the perforators were measured prior to sending to the supplier for evaluation and were found to be within specifications.Supplier evaluation did not confirm the complaint of "dullness".The customer¿s perforators met functional test acceptance criteria as well as dimensional test acceptance requirements for inner and outer drill flutes.Device history records (perforator assembly as well as inner and outer drill components) show all tests and inspections, including a drilling test on each perforator, met specifications.Note: further evaluation is presently being conducted to further determine the root cause of this complaint and include implementing more detailed work instructions at symmetry for the manual deburring process.Any addition evaluation reports for this complaint will be added to this file when completed.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: 5057831
• MDR Text Key: 25059506
• Report Number: 1226348-2015-10501
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Device Lot Number: PH022S AND FH022S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2015
• 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