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

Catalog Number 05.001.224

Device Problem Excessive Heating (4030)

Patient Problem Burn(s) (1757)

Event Date 01/01/2021

Event Type  Injury  

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.Additional narrative: concomitant med products and therapy dates: battery handpiece/modular, (b)(6) 2021.Udi: (b)(4).Reference manufacturer report number 8030965-2021-08487 for the battery handpiece/modular device as the devices were used together in the same event.

Event Description

This is report 2 of 2 of the same event: it was reported from (b)(6) that at the beginning of an unspecified surgical procedure, it was discovered that when the battery handpiece/modular device was activated while being used together with the sagittal saw attachment device, it heated up moderately when the cuts were started.It was reported that when the device was actuated again, it continued to heat up to the point where it caused a burn ¿injury¿ in the hands of the specialist.It was further reported that activation of the device was halted for a few minutes to check whether there were problems with the saw adapter device.According to the reporter, the saw adapter was replaced; however, the issue persisted.The reporter stated that they proceeded to place a wet compress and continued using the device since the procedure was in full session and a spare device was not available.It was not reported if there were any delays in the surgical procedure.There was patient involvement reported.It was reported that there was user injury.It was not reported if there was any medical intervention or prolonged hospitalization required as a result of this event.The exact date of the event was unknown.However, it was reported that the event occurred in 2021.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: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly.Correction: d4: incorrect serial number: the device serial number was incorrect in the initial report.The serial number has been updated from (b)(6) to (b)(6) and the udi has been updated.Udi: (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.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.Service review: a review of the service history record indicates that the device has been serviced within the last year for a service condition that is not relevant to the current reported condition.Device evaluation: quality engineering evaluated the device and determined that the reported condition of the device generating heat was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the device failed visual inspection.During the assessment it was found that the device was not working at all and was blocked.It was determined that the parts that translated the turning motion into an oscillation motion were blocked due to corrosion.Based on the additional information received from the user, it was determined that the user was not following the proper cleaning instructions from the ifu (instructions for use).It was determined that the most probable cause for the found defect was improper reprocessing by the customer.It was further determined that the device failed pretest for general condition, check for mechanical free movement, check the oscillation frequency with frequency meter.Assignable root cause was determined to be traced to environment, which is environmental conditions.

• Brand Name: SAGITTAL SAW ATTACHMENT, LONG, FOR TRS
• 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: 12664405
• MDR Text Key: 277361349
• Report Number: 8030965-2021-08489
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819377929
• UDI-Public: 07611819377929
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• 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: 10/11/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2018
• 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
• Patient Outcome(s): Required Intervention