MAUDE Adverse Event Report: SYNTHES GMBH LID-HANDPIECE/MODULAR FOR TRS; BATTERY, REPLACEMENT, RECHARGEABLE

Catalog Number 05.001.231

Device Problems Device Slipped (1584); Premature Separation (4045)

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

Event Date 03/06/2024

Event Type  malfunction  

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: d10.Concomitant med products and therapy dates: battery handpiece device (b)(6) 2024.D4: udi: lot/serial unknown.(b)(6).H4 device manufacture date: the device manufacture date is unavailable e1: reporters phone number was not provided.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

Event Description

This is report 2 of 2 for the same event.It was reported from japan that during a total knee arthroplasty (tka) surgical procedure it was observed that the lid of two handpiece device came loose.It was reported that after the procedure, the devices were checked by aligning the lid marks and twisting to lock and aligning the knob on the back of the lid with the lock mark.Then, the lid body turned and came off, even though it was not supposed to turn.This failure occurred with both devices.There was no patient involvement reported.There were no reports of injuries, medical intervention, or prolonged hospitalization.The exact date of the event was not reported; however, it was reported that the event occurred in 2024.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 in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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 medwatch, a follow-up medwatch will be filed as appropriate.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: h4: the device manufacture date was reported as unknown on the initial report.Please note that the date of manufacture has been updated accordingly.The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent 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.The actual device was returned for evaluation.Quality engineering evaluated the handpiece device and the reported condition that the lid of the device loosened was confirmed.The device was visually inspected and was found to have passed visual inspection.During the assessment it was found that the mode switch can be moved from the lock to the unlock position without the safety button being pushed.On the handpiece from this complaint a damage on the housing was found, where it was found that free cut in the housing for the inlaid piece from the lid¿s locking mechanism is damaged.This can happen when the lid for the handpiece is forcefully turned to remove it, while the mode switch is still in the locked position ¿ improper handling.This led to the found failure of the lid.It was determined that the most probable cause for the damaged locking mechanism is improper handling, which is user error.A review of the device history was performed and no non-conformances were detected related to the reported condition.

• Brand Name: LID-HANDPIECE/MODULAR FOR TRS
• Type of Device: BATTERY, REPLACEMENT, RECHARGEABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 18904143
• MDR Text Key: 337665674
• Report Number: 8030965-2024-03668
• Device Sequence Number: 1
• Product Code: MOQ
• UDI-Device Identifier: 07611819474901
• UDI-Public: 07611819474901
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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