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 Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is synthes sales rep.A review of the device history records has been requested.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 unknown date, a compact water bath was planned to use for bending an unknown rapidsorb plate for an unknown surgery.However, the device was repeatedly operated or stopped after turning the switch on.The surgery was completed without plate bending due to surgeon's decision.It was unknown if there was surgical delay.There was no adverse consequence to the patient.Patient status was stable.Concomitant device reported: unknown rapidsorb plates (part # unknown, lot # unknown, quantity 1).This report is for one (1) compact water bath.This is report 1 of 1 for complaint (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.Device history records review was completed for part: 05.725.010, lot: h098832-02.Manufacturing location: monument, release to warehouse date: may 27, 2016.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release 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: 8253980
• Report Number: 8030965-2019-59957
• Device Sequence Number: 16503818
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2018

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: 05.725.010
• Device Lot Number: H098832-02
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/24/2018
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention