MAUDE Adverse Event Report: SYNTHES GMBH RECON SAGITTAL SAW WITH KEY FOR TRS; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Model Number 05.001.240

Device Problem Intermittent Loss of Power (4016)

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

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 that the recon sagittal saw device would start working and then stop.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 the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The date of event was unknown.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: h4: the date of manufacture was reported as unknown in the initial report, the date of manufacture is may 16, 2013.G1-2: the manufacturer site name and address were unknown in the initial report.The location has been updated to waldenburg.The contact office name/address has been updated accordingly to reflect the corrected manufacturing facility.D11.Corrected data: the udi was reported as (b)(4) in the initial report and has been updated to (b)(4).

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: this device was returned for evaluation; however, during pre-repair assessment, it was determined that the device passed all pre-repair diagnostic assessment tests and no failure was identified.Therefore, the reported condition was not confirmed and an assignable root cause was not determined.

• Brand Name: RECON SAGITTAL SAW WITH KEY FOR TRS
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11039248
• MDR Text Key: 222687255
• Report Number: 8030965-2020-09842
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 10886982130150
• UDI-Public: 10886982130150
• 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,Followup,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 05.001.240
• Device Catalogue Number: 05.001.240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1