MAUDE Adverse Event Report: SYNTHES GMBH SAGITTAL SAW ATTACHMENT; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 532.021

Device Problems Device Reprocessing Problem (1091); Leak/Splash (1354); Excessive Heating (4030)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).

Event Description

It was reported from the united kingdom that the attachment device was getting hot and "oozing" black sludge.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device was returned for evaluation.During evaluation it was determined that the reported condition was not confirmed.Therefore, the assignable root cause was not determined.However, during evaluation, it was determined that the device was jammed/seized, had a broken swing fork and failed pre-test check oscillation frequency with frequency meter due to component wear.

• Brand Name: SAGITTAL SAW ATTACHMENT
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 18056307
• MDR Text Key: 327176039
• Report Number: 8030965-2023-13754
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 10886982240583
• UDI-Public: 10886982240583
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1