MAUDE Adverse Event Report: SYNTHES GMBH CHUCK WITH KEY F/BPL; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Model Number 530.730

Device Problems Detachment of Device or Device Component (2907); Complete Loss of Power (4015)

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

Event Type  malfunction  

Event Description

It was reported that the chuck with key device was not working while in use with a battery reamer device and battery oscillator device.During service and evaluation, it was observed that the device fell apart-unattached, moving parts did not move smoothly-chuck and had use error/misuse.It was further reported that the device failed pretest for general condition, check drill chuck function and check handpiece coupling.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 a surgical procedure or if a spare device was available for use.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.All available information has been disclosed.If additional information should 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.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.D10: concomitant med products and therapy dates: battery reamer device, battery oscillator device, unknown date.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition that the device fell apart-unattached, identified during service and repair was confirmed.The assignable root cause was determined to be traced to maintenance.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.H10 additional narrative: b5: it was further reported that during service and evaluation, it was observed that the device also did not function.D4: incorrect lot number: the device serial number was incorrect in the initial report.The serial number has been updated from (b)(6).

• Brand Name: CHUCK WITH KEY F/BPL
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES PRODUKTIONS GMBH; hauptstrasse 24; waldenburg 4437 ; SZ 4437
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 16852438
• MDR Text Key: 314361548
• Report Number: 8030965-2023-05513
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 10886982240156
• UDI-Public: 10886982240156
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 530.730
• Device Catalogue Number: 530.730
• Device Lot Number: 3628003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1