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

Catalog Number 26-1221

Device Problem Failure to Auto Stop (2938)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(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 ous affiliate, a perforator failed to disengage.Further information is being requested.

Manufacturer Narrative

Complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and 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: 8284179
• MDR Text Key: 134310163
• Report Number: 1226348-2019-10055
• 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: foreign,health professional,u
• Type of Report: Initial,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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 01/29/2019
• Supplement Dates Manufacturer Received: 03/04/2019
• Supplement Dates FDA Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other