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

Catalog Number 26-1221

Device Problem Failure to Auto Stop (2938)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported by the ous affiliate, when making a trepan hole, a perforator would not release.Operation lengthened by 20 minutes.

Manufacturer Narrative

The affiliate was contacted regarding product returned; however, the product was not returned for evaluation.As such it is not possible to evaluate the product and determine the root cause of this complaint.We will continue to monitor for this or similar complaints for this product code.A review of the lot history records did not show any anomalies during the manufacturing process.At this time this complaint is considered to be closed, should the product be returned at a later date this complaint will be re-opened and an investigation will be performed.

Manufacturer Narrative

Upon completion of the investigation it was noted that the unit was visually inspected utilizing unaided eye.No anomalies were observed.Unit was found to performed as intended.Unit completed testing (5 holes) and was found to performed as intended.The dhr (pn: 261221_bn: h60844) was reviewed and it was verified that there were no anomalies during the manufacturing process.Complaint could not be verified.Unit was found to meet all acceptance criteria.

Manufacturer Narrative

Device was returned for evaluation.A follow up report will be filed upon completion of the investigation.

• 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: 6878598
• MDR Text Key: 87197370
• Report Number: 1226348-2017-10681
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup

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
• Device Lot Number: H60844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 09/20/2017
• Supplement Dates Manufacturer Received: 09/26/2017; 11/27/2017; 01/15/2018
• Supplement Dates FDA Received: 10/12/2017; 11/27/2017; 01/22/2018
• 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