MAUDE Adverse Event Report: SYNTHES GMBH BATTERY HANDPIECE/MODULAR FOR TRS; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 05.001.201

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.Concomitant med products and therapy dates: sagittal saw attachment, (b)(6) 2021.Udi: (b)(4).Reference manufacturer report number 8030965-2021-08489 for the sagittal saw attachment device as the devices were used together in the same event.

Event Description

This is report 1 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: 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: the actual device was returned for evaluation.Quality engineering evaluated the device.A functional assessed was performed and it was determined that the device failed visual inspection.During the assessment, it was found that the bearings were not moving freely, which was determined to be the cause of the reported heat.It was further determined that the seals were defective.It was determined that the device generated heat, had a leak tightness test failure, and the moving parts did not move smoothly.It was further determined that the device failed pretest for general condition, leakage test using bubble emission technique and check for mechanical free moving.Based on the additional information sent by the service center, it was reported that the user was not following the reprocessing instruction for use (ifu), which most probably led to the seal defect and damaged bearings.It was reported that the user was informed about the reprocessing instruction (part of ifu) and related requirements.Therefore, the reported condition of the device heating up was confirmed.The assignable root cause was determined to be due to improper reprocessing, which is environment.

• Brand Name: BATTERY HANDPIECE/MODULAR FOR TRS
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• 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: 12664404
• MDR Text Key: 277384060
• Report Number: 8030965-2021-08487
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819977815
• UDI-Public: 07611819977815
• 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
• 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: 05.001.201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2018
• 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