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

Catalog Number 532.021

Device Problem Premature Separation (4045)

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 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 of the device has been completed, a supplemental medwatch report will be sent accordingly.Udi (b)(4).

Event Description

It was reported from (b)(6) that the blade device came off the attachment device when the handpiece device started to move.It was not reported if the event occurred during a surgical procedure.It was not reported if there was a delay to a planned procedure.It was not reported if there was a spare device available for use.There was no patient involvement reported.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 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.The actual device was returned for evaluation.The attachment device was evaluated and the reported condition that the blade device came off the device when the handpiece device started to move was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device could not secure/lock a cutter.The assignable root cause of this condition was determined to be traced to component failure due to wear.

• Brand Name: SAGITTAL SAW ATTACHMENT
• 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: 12706225
• MDR Text Key: 284647371
• Report Number: 8030965-2021-09064
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819107182
• UDI-Public: 07611819107182
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• 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: 10/25/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2016
• 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