MAUDE Adverse Event Report: UNKNOWN DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACC.

Device Problem Failure to Auto Stop (2938)

Patient Problem No Information (3190)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation a follow up report will be filed.

Event Description

During procedure perforator failed to disengage.They were able to remove the drill prior to any patient injury.No reported patient harm or delay in surgery greater than 30 minutes.

Manufacturer Narrative

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

Manufacturer Narrative

Upon completion of the investigation it was noted that the device was visually inspected utilizing unaided eye.The unit was received incomplete, damaged and disassembled.It was noted that the blue sleeve (pn:260122404) had a 1/8¿ section of the larger diameter broken off, the product (eto) label (260101596) was illegible and the drive pin (pn:260122005) and spring (pn:260122006) were both missing.No additional anomalies were observed.The unit was first reassembled utilizing a new drive pin (bn: 75fg2805), spring (bn: aa20048433), blue sleeve (bn: 129016624) and bearing (pn:260122008, bn: 136640938).Once reassembled, the unit was found to performed as intended.After being reassembled (as described above), the unit completed testing (5 holes) and was found to performed as intended.Due to the lot number being unknown and illegible, a dhr review could not be performed.Complaint could not be verified.Unit was found to meet all applicable acceptance criteria.The most recent complaint and smt presentation has been reviewed and this product family did not exceed the upper control limit for complaints.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: UNKNOWN DISPOSABLE PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 7142226
• MDR Text Key: 95796947
• Report Number: 1226348-2017-11005
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2018
• 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