MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH COMPACT WATER BATH; BATH, INCUBATORS/WATER, ALL

Catalog Number	05.725.010
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the switch lamp on the water bath (05.725.010) was switching on and off repeatedly during the maxillary and mandibular osteotomy surgery.The surgery was completed without a surgical delay.There was no harm to the patient.No further information is available.This report is for one (1) compact water bath.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: investigation summary: investigation was performed by the manufacturer/supplier: precision assembly.Reference pi attachment "complaint: (b)(4)".Flow: device interaction/functional.Visual inspection: visual inspection of the returned water bath revealed the light pipe component fell apart from its assemble location.Functional testing: the light pipe was reassembled and the supplier performed a functional test.No functional issues were observed during functional testing by the supplier.Dimensional inspection: dimensional inspection was not performed by the supplier as the component was reassembled and the device passed functional testing.Document/specification review: the following manufactured and current drawings were reviewed during investigation.No design issues were observed during investigation.Conclusion: although an intermittent functional condition was not replicated with the returned device, the complaint was confirmed during investigation, as the light pipe issue would have presented as an intermittent condition to the user.No manufacturing issues were identified during investigation.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.A root cause could not be determined, however, it is possible the device was exposed to extreme forces during shipping and handling.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot: part#: 05.725.010, synthes lot#: 7962542-27, supplier lot#: 7962542-27, release to warehouse date: aug 04, 2015.Manufactured by synthes monument: nr-0010618 was generated as all devices in this lot were labeled with the same serial number.This non-conformance is not relevant to the complaint condition since all devices were sent back and re-labeled with the correct serial number.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: COMPACT WATER BATH
• Common Device Name: BATH, INCUBATORS/WATER, ALL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9677898
• Report Number: 8030965-2020-00907
• Device Sequence Number: 13596262
• Product Code: JTQ
• UDI-Device Identifier: 07611819618060
• UDI-Public: (01)07611819618060
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 05.725.010
• Device Lot Number: 7962542-27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 04/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1