MAUDE Adverse Event Report: AESCULAP AG SEGMENT SAW F/GB124R 32/12/0.5/0.8MM; POWER SYSTEMS ORTHOPAEDICS

Model Number GC500R

Device Problem Unclear Information (4052)

Patient Problem Laceration(s) (1946)

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.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.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.Additional information was received on (b)(6) 2018: the technician required no medical attention and it was a minor cut.

Manufacturer Narrative

We did not received the complained products for the investigation.The case occurred pre-operatively.The saw blade do not required a batch management, therefore it is not possible to review the device history records.The failure is most probably usage related.The distributor complains, that the mentioned saw blade were supplied assembled in the past, whereas they are supplied disassembled now.Furthermore, the distributor states that the ifu is not sufficient regarding the assembly instructions.In fact, it is correct that the saw blade are now delivered dissembled due to a change of the packaging in the past.However, the customers (hospitals) had to disassemble/assemble the saw blade in the past already after each usage to perform a correct cleaning according to the ifu.Therefore this procedure is not new.According to the statistical evaluation, there were no further complaint regarding this issue in the past, hence no indication regarding a lack of information with the ifu.We assume that a usage/handling related failure led to the injury.A capa is not necessary.Excerpt of ifu.Dismantling prior to carrying out the reprocessing procedure.Disassemble the product immediately after use, as described in the respective instructions for use.Mounting a saw blade on the shaft.Install saw blade 6 in the intended position on shaft 8.Be careful to position pin 7 ion saw blade slot 5.Install disk 4 in such a way that a slit engage over pin 7.Position lock washer 3 and not 2 and tighten the nut with double wrench 1.

• Brand Name: SEGMENT SAW F/GB124R 32/12/0.5/0.8MM
• Type of Device: POWER SYSTEMS ORTHOPAEDICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7994775
• MDR Text Key: 124698998
• Report Number: 9610612-2018-00465
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was 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: GC500R
• Device Catalogue Number: GC500R
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/31/2018
• Date Manufacturer Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1