MAUDE Adverse Event Report: AESCULAP AG SAGITTAL SAW ATTACHMENT F/GA344/GA844; POWER SYSTEMS

Model Number GB891R

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 08/03/2020

Event Type  Injury  

Manufacturer Narrative

Investigation on going.Additional information / results will be submitted in a supplemental report.

Event Description

It was reported that there was an issue with sagittal saw.It was reported that the holding clamb springs apart during sawing.The malfunction occurred during a foot operation on 08.03.2020.The operation was delayed by about 10 minutes to get and open another screen.There was no patient harm.This event/malfunction prolonged the surgery for 10 minutes.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

The investigation has been carried-out by the aesculap technical service (ats).The attachment has been distributed in march 2018.A repair or maintenance can not be found in our database.A functional check could not be performed, due to the fact that the screw connection (ga831208) has became lose.This connection is secured with loctite 243.A detailed inspection of the screw connection reveals that almost no glue could be found on both relevant parts, see figure 2 and 3.Due to the fact that this is an individual case, we suspect a manufacturing related failure.As a measure the responsible person from the production department will be informed about this case.

• Brand Name: SAGITTAL SAW ATTACHMENT F/GA344/GA844
• Type of Device: POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10546978
• MDR Text Key: 207343334
• Report Number: 9610612-2020-00514
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GB891R
• Device Catalogue Number: GB891R
• Device Lot Number: 52393645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 09/28/2020
• Supplement Dates FDA Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention