MAUDE Adverse Event Report: SYNTHES GMBH SAGITTAL SAW ATTACH/LG FOR TRAUMA RECON; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 05.001.224

Device Problems Physical Resistance/Sticking (4012); Complete Loss of Power (4015)

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.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.A device history review was performed which indicated that the device was processed through the normal manufacturing and inspection operations with no re-work or nonconformities noted.The assignable root cause was determined to be due to component failure.Udi:(b)(4).

Event Description

It was reported from (b)(6) that during service and evaluation, it was determined that the saw attachment device moving parts did not move smoothly, was frozen/would not move and did not function.It was further determined that the device failed pretest for check of mechanical free movement, check general function in running mode and check the oscillation frequency.It was noted in the service order that the device was not working.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in (b)(6).All available information has been disclosed.If additional information should become available, an additional report will be submitted accordingly.

• Brand Name: SAGITTAL SAW ATTACH/LG FOR TRAUMA RECON
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• 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: 12151154
• MDR Text Key: 261039799
• Report Number: 8030965-2021-05679
• Device Sequence Number: 1
• Product Code: MOQ
• UDI-Device Identifier: 07611819377929
• UDI-Public: 07611819377929
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• 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: 06/22/2021
• Date Manufacturer Received: 07/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2019
• 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