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

Catalog Number 532.021

Device Problems Device-Device Incompatibility (2919); Premature Separation (4045)

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

Event Date 03/24/2021

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 has been returned and is currently pending evaluation.Once the evaluation has been completed, a supplemental medwatch report will be sent accordingly.  udi: (b)(4).

Event Description

It was reported from (b)(6) that the sagittal saw attachment device saw holder unscrewed itself.It was further reported that the device holder loosened and did not hold the saw blade.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.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.

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.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.H10 additional narrative: device evaluation: the actual device was returned for evaluation.During repair, it was determined that the reported condition of cannot secure/lock cutter was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the device had a worn bearing, did not function, component damage and a worn coupling.It was further determined that the device failed pretest for verify if secured with safety pin, check oscillation frequency with frequency meter, check slide sleeve for positioning of attachment, check the handpiece coupling and check the function of the quick saw blade coupling.It was noted that the bearing was defective.The assignable root cause was determined to be traced to maintenance, which is improper maintenance.

• 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: 11635371
• MDR Text Key: 246818434
• Report Number: 8030965-2021-02647
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819107182
• UDI-Public: 07611819107182
• 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
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• 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
• Date Returned to Manufacturer: 04/08/2021
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1