MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC SAGITTAL SAW ATTACHMENT FOR TRS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 05.001.223

Device Problem Fluid/Blood Leak (1250)

Patient Problem Skin Irritation (2076)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This is report 3 of 3 for the same event.It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the saw attachment device began secreting a blackish viscous material compatible with oil which constantly contaminated the operative area while in use with the battery handpiece device.It was reported that after ten minutes of use, the equipment stopped working for which the surgery was affected.It was reported that alternative methods where used to continue with surgical intervention.The reporter indicated that the surgery was delayed by 15 to 20 minutes.It was reported that the oily liquid produced redness in the operated area on the patient and for that reason the patient was hospitalized for an additional five days.Multiple attempts have been made for additional information.All available information has been disclosed.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.The actual device was returned for evaluation.Quality engineering evaluated the device the reported condition could not be re-produced and therefore was not confirmed and an assignable root cause was not determined.However, during repair, it was determined that the attachment's interior mechanics were running rough and severely corroded, and the device heated up quickly.It was also determined that the device failed pre-test for free movement.The leakage that was reported may have been due to excessive heat inside of the attachment which could result in an increase of pressure.No liquid was found inside of the attachment, however traces of residue were detected.During review of the device manufacturing records for this device it was found that there were no anomalies that occurred during the manufacturing or processing of the device that would have been expected to cause or contribute to the reported event.The assignable root cause of the corroded internal components was determined to be due device design.This issue has been escalated to a capa.The assignable root cause for the heat was determined to be due to premature wear.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.Upon follow up with the reporter it was reported that the patient that was involved in the event was a 71 year old female.No medical intervention or x-ray were required.The patient was treated for infection.There was no wound culture performed.It is unknown what antibiotic, if any was given.Signs of infection (unspecified) were evident two to three days post operation.A new engine was used to complete the surgery.According to the doctor, he could not identify which device the leak was coming from.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SAGITTAL SAW ATTACHMENT FOR TRS
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8320327
• MDR Text Key: 135534802
• Report Number: 8030965-2019-60669
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 10886982130013
• UDI-Public: 10886982130013
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Date Manufacturer Received: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HANDPIECE DEVICE; SAW ATTACHMENT DEVICE; HANDPIECE DEVICE; SAW ATTACHMENT DEVICE
• Patient Outcome(s): Hospitalization; Required Intervention