MAUDE Adverse Event Report: AESCULAP AG DEEP CUTT.SAW F/GB124R 45/20/0.6/ POWER SYSTEMS ORTHOPAEDICS

Model Number GC502R

Device Problem Unclear Information (4052)

Patient Problem Laceration(s) (1946)

Event Date 09/17/2018

Event Type  Malfunction  

Manufacturer Narrative

(b)(4). Reported device not marketed in the u. S. , however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u. S. Manufacturing site evaluation: the device was not returned to the manufacturer. An evaluation of the complaint will be performed based on information obtained in the complaint. Pending further information. If additional information becomes available a supplemental report will be submitted.

Event Description

It was reported by the user facility to the company sales representative, "the sternum saw blades now come unassembled. The manufacturer only supplied a picture of how the pieces go together. There were no instructions or orientation of blade on the shaft or how tight the nut should be installed. As a facility service technician was installing the blade onto the shaft, one of the two aesculap wrench's slipped off the nut and cut the technicians finger. The facility had already brought this forward as a health and safety issue, if the facility staff were to assemble these on site. " there was no specific information provided regarding the extent of the injury other than it was a minor cut. The product was not being used on a patient at the time of the incident. There was no delay in critical therapy when problem was noted. The device and components will not be sent back to aesculap. Updated information received on 15oct2018: there was no medical attention required for the technician.

• Brand Name: DEEP CUTT.SAW F/GB124R 45/20/0.6/
• Type of Device: POWER SYSTEMS ORTHOPAEDICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 7994766
• MDR Text Key: 125612532
• Report Number: 9610612-2018-00464
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (Y/N): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: FOREIGN,USER FACILITY

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/28/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 10/23/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: OTHER
• Device MODEL Number: GC502R
• Device Catalogue Number: GC502R
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 10/31/2018
• Event Location: No Information
• Date Manufacturer Received: 10/31/2018
• Was Device Evaluated By Manufacturer?: Yes
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown