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 10/11/2018

Event Type  Injury  

Manufacturer Narrative

Udi -- (b)(4).Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

As reported by the affiliate, a perforator failed to disengage.The perforator was mounted on the motor to make the trepanations; when the drill started the perforator failed to stop and resulted in two hard mater injuries.There were no reports of surgical delays.

Manufacturer Narrative

Udi: (b)(4).It was initially reported that the device would be returned for evaluation.However, multiple attempts to obtain the sample were unsuccessful.This report has been updated to reflect the corrected information.Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found the device conformed to specification when released to stock.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: CODMAN DISP PERFORATOR 11MM
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8023904
• MDR Text Key: 125644510
• Report Number: 1226348-2018-10781
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/13/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 26-1222
• Device Lot Number: HQ1208
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/13/2018
• Initial Date FDA Received: 10/31/2018
• Supplement Dates Manufacturer Received: 01/03/2018
• Supplement Dates FDA Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other