MAUDE Adverse Event Report: SYNTHES GMBH RECIPROCATING SAW ATCH FOR PEN DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 05.001.040

Device Problem Excessive Heating (4030)

Patient Problem Burn(s) (1757)

Event Date 12/22/2020

Event Type  Injury  

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.Concomitant medical devices and therapy dates: attachment devices, pen drive device, console device, hand switch device and cable device; (b)(6) 2020 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

This is report 2 of 2 for the same event.It was reported from australia that during an unspecified surgical procedure, it was observed that while the pen drive device was being used with the reciprocating saw attachment device, the device heated up and came into contact with the patients lip causing a burn.It was reported that as a result of the burn on the patient's lip, there was an ulcer on the inside of the lip.It was reported that a gel was used to ease the burn.It was reported that the device was being used with a console device, (2) attachment devices, cable device and a hand switch device.It was reported that the surgery was completed with minimal delay.It was not reported whether a spare device was available for use.There was patient involvement.There were no reports of 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.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: the actual device was returned for evaluation.During repair by quality engineering, it was determined that while running the device it emitted dust and developed heat after a few seconds.Dents and scratches were detected from the outside and the interior gears were not running smoothly.During dismantling, it was observed that the interior mechanics were heavily worn and corroded.The device failed pre-repair diagnostic for general condition and check of free moving.Therefore, the reported condition was confirmed.A device history review was performed which indicated that there were no relevant issues identified during the manufacture of the device that may have contributed to the reported condition.The assignable root cause was determined to be due to improper maintenance.

• Brand Name: RECIPROCATING SAW ATCH FOR PEN DRIVE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11200838
• MDR Text Key: 230081406
• Report Number: 8030965-2021-00304
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819167902
• UDI-Public: 07611819167902
• 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: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.040
• Device Lot Number: 8523919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention