MAUDE Adverse Event Report: SYNTHES GMBH SAGITTAL SAW ATTACH/LG FOR TRAUMA RECON; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 05.001.224

Device Problems Complete Loss of Power (4015); Excessive Heating (4030); Difficult or Delayed Separation (4044)

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

Event Date 05/18/2021

Event Type  malfunction  

Event Description

It was reported from (b)(6) that during a total knee replacement procedure while doing the femur cuts, the motor began to heat up and the handpiece began to lower its power.The battery was charged since it was evident that it had one less load point, while the battery was being loaded it was decided to remove the saw anchor.It was reported that it was not possible to adjust it after several minutes and maneuvers such as placing a wet compress to lower the heat and manipulate the anchor it was finally able to be released.It was reported that the battery was re-assembled and the motor was activated running.The cuts of the femur and tibia were finished, but when cutting the patella it stopped working.So last measure it was decided to use a small saw motor of the institution to finish the cut.It was not reported if there were any delays in the surgical procedure.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

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.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.(b)(4).

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: after review of the event it was determined that this is report 1 of 2 for the same event.D10.Concomitant med products and therapy dates: battery handpiece device, battery device; (b)(6) 2021.Please note that this medwatch report (8030965-2021-04286) is related to medwatch report 8030965-2021-04304 as the products were used together in the same event.

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: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to component wear.

• Brand Name: SAGITTAL SAW ATTACH/LG FOR TRAUMA RECON
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11884705
• MDR Text Key: 280519227
• Report Number: 8030965-2021-04286
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819377929
• UDI-Public: 07611819377929
• 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,Followup
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 06/01/2021; 08/12/2021
• Supplement Dates FDA Received: 06/02/2021; 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1