MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Model Number 26-1221

Device Problems Break (1069); Entrapment of Device (1212); Failure to Auto Stop (2938)

Patient Problem No Code Available (3191)

Event Date 11/15/2017

Event Type  malfunction  

Event Description

The perforator is supposed to stop when it is finished cutting through bone.In this case the perforator did not stop and the perforator managed to get stuck in patient.The perforator was removed with a kelly clamp during which the perforator broke apart.Manufacturer response for perforator, codman disposable perforator (per site reporter): visually inspected utilizing unaided eye.The unit was received incomplete, damaged and disassembled.It was noted that the blue sleeve had a 1/8" section of the larger diameter broken off, the product (eto) label was illegible and the drive pin and spring were both missing.No additional anomalies were observed.The unit was first reassembled utilizing a new drive pin , spring , blue sleeve and bearing.Once reassembled, the unit was found to performed as intended.Complaint could not be verified.Unit was found to meet all applicable acceptance criteria.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7406361
• MDR Text Key: 104670613
• Report Number: 7406361
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 26-1221
• Device Catalogue Number: 261221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO