MAUDE Adverse Event Report: SYNTHES GMBH SAGITTAL SAW ATTACHMENT, LONG, FOR TRS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 05.001.224

Device Problems Complete Loss of Power (4015); Excessive Heating (4030)

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

Event Date 01/01/2021

Event Type  malfunction  

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.Udi: (b)(4).

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the when the saw device was activated and came into contact with the bone, the part of the saw adapter device overheated and began to work slowly.According the reporter, the device stopped operating, was removed and reassembled however, it does not work again.There was a fifteen minute delay to the surgical procedure.A spare device was not available so the procedure was completed using a chisel device and hammer device as there was no other motor available at the facility there was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have occurred in 2021.All available information has been disclosed.If additional information should become available, a supplemental medwatch 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.H10 additional narrative: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device reported condition of overheating was not confirmed.It was further noted that the device did not function, the moving parts did not move smoothly, had component damage and would not move.The device also failed pretests for check the oscillation frequency with frequency meter, check general function in running mode, check for mechanical free movement and general condition.The assignable root cause was traced to component failure due to normal wear.

• Brand Name: SAGITTAL SAW ATTACHMENT, LONG, FOR TRS
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6107428552
• MDR Report Key: 12683385
• MDR Text Key: 278126707
• Report Number: 8030965-2021-08901
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819377929
• UDI-Public: 07611819377929
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

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: 12/02/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 12/02/2021
• Supplement Dates FDA Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1