MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC BATTERY OSCILLATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.710

Device Problem Leak/Splash (1354)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

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.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).

Event Description

It was reported that during an unspecified surgical procedure, it was discovered that the battery oscillator device leaked dark fluid in the patient.It was reported that an immediate intervention took place which was wound irrigation with saline and beta-dine mixture.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There was patient involvement reported.It was not reported if there was prolonged hospitalization.The reporter stated that the status of the patient post-surgery was fine.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

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 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.Correction: g1-2: manufacturing site name: the manufacturer location was incorrectly documented as waldenburg in the initial report.The location has been updated to oberdorf.The contact office name/address has been updated accordingly to reflect the corrected manufacturing facility.If additional information should become available, a supplemental medwatch will be submitted accordingly.

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 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.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that a fluid leak was not noted during evaluation.Therefore, the reported condition was not confirmed, and an assignable root cause was not determined.However, it was determined that the device failed pretest for general condition and trigger test.It was further determined that the trigger became loose from the electric control unit (ecu), and the lock ring and guide sleeve were worn.It was determined that the moving parts did not move smoothly.The assignable root cause was determined to be due to component failure from normal wear out from use.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

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 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.H6: service history review: the actual device was not returned for evaluation; therefore, the reported condition was not confirmed.However, a service history review was performed which indicated that the device was serviced over a year for a service condition that is not relevant to the current reported condition.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.

• Brand Name: BATTERY OSCILLATOR II FOR BPL II
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9918147
• MDR Text Key: 195317089
• Report Number: 8030965-2020-02089
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819491847
• UDI-Public: 07611819491847
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/11/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 530.710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 04/02/2020
• Supplement Dates Manufacturer Received: 04/30/2020; 05/05/2020; 05/14/2020
• Supplement Dates FDA Received: 05/01/2020; 05/06/2020; 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention