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

Catalog Number 26-1221

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

Udi - (b)(4).It has been reported that the device will be returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that the perforator broke during use, the blue outer plastic part and the white inner plastic part broke during perforation.The drill edge was stuck in bone of the skull.The remained edge was retrieved and the procedure was continued.It was unknown whether the hole step and bone pad were formed.No further information was provided by the hospital.The product will be returned to your site.

Manufacturer Narrative

The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The device was returned for evaluation.The perforator was visually examined.The unit was disassembled and exhibited damage unrelated to the manufacturing process on the outside body of the outer drill.Due to the condition of the device as it was received, no functional testing was possible.The perforator was resleeved and testing was then able to be performed.A series of holes were drilled without issue.The device functioned as intended.A review of manufacturing records could not be performed, as no lot number was provided.Based on the results of the investigation, it was confirmed that the perforator was damaged; however, with the information provided, no root cause could be determined.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7647828
• MDR Text Key: 113009198
• Report Number: 1226348-2018-10463
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 26-1221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Manufacturer Received: 06/14/2018
• Initial Date FDA Received: 06/28/2018
• Supplement Dates Manufacturer Received: 07/10/2018; 09/12/2018
• Supplement Dates FDA Received: 08/02/2018; 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1