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

Catalog Number 05.001.201

Device Problems Noise, Audible (3273); Physical Resistance/Sticking (4012); Complete Loss of Power (4015)

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

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The actual device was returned for evaluation.Quality engineering evaluated the handpiece device and the reported condition that the device did not work with the battery in and the trigger pushed was confirmed.An assessment was performed and it was determined that the device had a sticky trigger, moving parts of the device did not move smoothly, there was excessive debris on the ball bearing causing the device not to rotate properly, there was unknown debris on the ball bearing, the ball bearing seized due to the debris on the outer edge of the bearing, and the device did not run.There was also excessive corrosion on the internal components.It was further determined that the device failed pretest for check for mechanical free movement assessment, check for sticky triggers, and check for functionality of the device.The assignable root cause of these conditions was determined to be traced to maintenance, which is user error/misuse/abuse.Udi: (b)(4).

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure it was observed that, with the battery device in, and the trigger button pushed, the handpiece device made a noise but the device did not work.During in-house engineering evaluation it was determined that the device had a sticky trigger.There were no reports of injuries, medical intervention, or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• 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: 11003360
• MDR Text Key: 221289422
• Report Number: 8030965-2020-09518
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819977815
• UDI-Public: 7611819977815
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• 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
• Date Returned to Manufacturer: 10/21/2020
• Date Manufacturer Received: 12/02/2020
• Date Device Manufactured: 11/29/2012
• 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