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

Catalog Number	05.001.231
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Additional 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.H11 additional narrative: investigation summary: a video was provided by the customer for evaluation.Based on the provided video, it was determined that the device had the following failures: unexpected disengagement - battery/case/lid and deformed/bent - housing.Therefore, the reported condition was confirmed.However, an assignable could not be determined.
Additional 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.H10 additional narrative: h4: the lot number was unknown; therefore, the device manufacture date is unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
This is report 2 of 2 for (b)(4).It was reported from colombia that during an unspecified surgical procedure, a battery handpiece device and a lid for handpiece device were used together.According to the report, the devices were tested at the beginning of the procedure before incising the patient¿s skin, but they were not able to close the lid device on the battery handpiece device.It was reported that the surgical team was already sterile, and the patient was already under spinal anesthesia when the event occurred.It was reported that they tried using another handpiece device from a competitor¿s brand but it did not fit the insertion system for the drills.It was reported that although an attempt was made to solve this problem with the closure of the handpiece device with the lid device, they decided to cancel the procedure.The status of the patient was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: LID-HANDPIECE/MODULAR FOR TRS
• Common Device Name: 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: 20327543
• Report Number: 8030965-2024-12024
• Device Sequence Number: 12728431
• Product Code: MOQ
• UDI-Device Identifier: 10886982130143
• UDI-Public: 10886982130143
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 05.001.231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown