MAUDE Adverse Event Report: AESCULAP, INC. AESCULAP KERRISON; RONGEUR, POWERED

Model Number 281-061

Device Problems Material Separation (1562); Naturally Worn (2988)

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

Event Date 03/09/2017

Event Type  malfunction  

Event Description

At the beginning of the procedure, the kerrison #3 bone punch fell apart before use on the patient, and the screw was noted to be missing.The item was removed from service immediately after all pieces were collected.The mobile repair services inspected the instrument and determined that all pieces in fact were present.It is believed that the failure occurred due to normal wear and tear.The age of the item is approximately 15 years.The instrument was repaired by mobile repair tech and deemed appropriate for use.The item was permanently removed from service and new devices were ordered (b)(6).Manufacturer response for surgical instrument, aesculap kerrison (per site reporter).Mobile repair serves inspected the instrument and determined that all pieces were present.It is believed that this occurred from normal wear and tear.The approximate age of the device is 15 years.The instrument was repaired by the mobile repair tech and deemed appropriate to use.However, the item was permanently removed from service and new kerrison's were ordered (b)(6).

• Brand Name: AESCULAP KERRISON
• Type of Device: RONGEUR, POWERED
• Manufacturer (Section D): AESCULAP, INC.; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 6854555
• MDR Text Key: 85636385
• Report Number: 6854555
• Device Sequence Number: 1
• Product Code: HAD
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 281-061
• Device Catalogue Number: 281-061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2017
• Device Age: 15 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: UNKNOWN. THE PATIENT WAS UNDERGOING A L4 TO S1 LAM
• Patient Age: 62 YR
• Patient Weight: 68