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

Model Number 532.021

Device Problems Mechanical Jam (2983); Noise, Audible (3273); Excessive Heating (4030)

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

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.The actual device was returned for evaluation.During evaluation it was determined that the initial reported condition of the device was making a grinding noise and heating up was not confirmed.Therefore, the assignable root cause was not determined.However, during evaluation, it was confirmed that the device jammed/seized.It was further determined that the moving parts of the device did not move smoothly, there was corrosion/rusting/pitting, and foreign substance/debris.The assignable root cause was determined to be due to improper maintenance.(b)(4).

Event Description

It was reported that during that during an unspecified veterinary surgical procedure, it was discovered that the sagittal saw attachment device made a loud noise and then became really hot and seized up.It was reported that there was a thirty-minute delay to the surgical procedure and the surgeon had to remove the bone manually.There was no human patient involvement as the device was used in a veterinary procedure.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: SAGITTAL SAW ATTACHMENT
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11958046
• MDR Text Key: 280539323
• Report Number: 8030965-2021-04420
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 10886982240583
• UDI-Public: 10886982240583
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 532.021
• Device Catalogue Number: 532.021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1