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).

• 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
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; 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
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 09/17/2020
• 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
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/28/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 01/26/2018
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient TREATMENT DATA

Date Received: 09/17/2020 Patient Sequence Number: 1