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

Catalog Number 530.710

Device Problems Fluid/Blood Leak (1250); Device Contamination with Chemical or Other Material (2944)

Patient Problem Not Applicable (3189)

Event Date 12/12/2017

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.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.

Event Description

It was reported that during a total hip arthroplasty surgical procedure, it was observed that moisture was coming from underneath black plastic collar of the battery oscillator saw device at the time of resecting the femoral head.It was reported that there was significant concern whether the liquid material may have compromised patient sterility.It was reported that there was a 30-minute delay in the procedure due to concern over the prudence of continuing the procedure versus taking alternative action.It was reported that the prophylaxis antibiotics were administered intra-operatively by the placement of antibiotic beads (resorbable beads impregnated with two grams of vancomycin and 400 milligrams of tobramycin) to the patient as a result.The patients post-operative condition was not reported.It was not reported if there was a need for additional medical intervention.It was not reported if prolonged hospitalization was required due to this event.It was not reported if a spare device was available for use.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Device was used for treatment, not diagnosis.The actual device was returned for evaluation.The battery oscillator device was evaluated and the reported condition of residual moisture was confirmed.It was noted that the device was functional and passed the pre-repair diagnostic assessment.During repair it was observed that the contacts on the device were corroded, there was liquid on the guide sleeve full load components, and liquid in the electronic control unit.The assignable root cause was determined to be due to improper cleaning, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device evaluation update: clinical engineering visited the user facility to further assess the reported condition of devices not being fully dry following decontamination and sterilization process.An assessment was performed of the decontamination process which determined that the reciprocating saw devices were not being processed in a separate basket and the dry time on the washer/sanitizer was set to 10 minutes instead of 40 minutes as the instructions for use call for.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Please note that a voluntary medwatch report (mw-5076071) was received.The information states that although sterilization practices have been changed, they continue to have residual moisture contained, even after all recommendations had been followed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• 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: 7180653
• MDR Text Key: 96936039
• Report Number: 8030965-2018-50248
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 7611819491847
• UDI-Public: (01)7611819491847(11)140702
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.710
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Date Manufacturer Received: 04/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 91