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

Catalog Number 05.001.224

Device Problem Mechanical Jam (2983)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 02/27/2020

Event Type  Injury  

Manufacturer Narrative

Reporters phone number was not provided.(b)(4).The actual device has been returned for evaluation.Quality engineering is currently evaluating the device however, since the investigation is still on-going, the assignable root cause could not be determined at this time.Once investigation has been completed, a supplemental medwatch will be submitted accordingly.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure for a total knee replaceable, it was observed that the attachment device did not show any signs of movement (rotation/oscillation/reciprocation) when the motor was working.It was reported that the when the device started cutting, it began to ¿bother¿ and stopped working.According to the reporter, an initial cut to the patella was performed and then the saw jammed and stopped operating.It was further reported that a spare device was sterilized, however the device was still wet and could not be used.It was reported that the procedure was stopped and cancelled, and the patient had to be sewn up until a future procedure.It was reported that the device was tested before the procedure with all its adapters, and worked normally.There was patient involvement reported.The current condition of the patient was not known.There were no reports of injuries or prolonged hospitalization.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.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.B5: additional information: upon subsequent follow-up with the reporter, additional information was received.The reporter stated that the procedure being performed was a total knee replacement.It was noted that the motor was running at the time the user made an incision and failed at the time of making the cut in the kneecap.The failure of the saw head of the motor occurred during the beginning cuts of the ball joint, which is the first part of the specialist technique.It was further reported that the saw head of a motor that was used in the surgery prior to this was sterilized, however the device was still wet and therefore could not be used; patient was rescheduled for another day with anesthesia.This information does not change the reportabilty of the file.H6: device history review: upon further investigation of the device evaluation, it was determined that a review of the device history was performed and no non-conformances were detected related to the reported condition.

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 will be filed as appropriate.B5: additional information: upon subsequent follow-up with the reporter, additional information was received.The reporter stated that the additional procedure was completed on (b)(6) 2020.The surgical procedure was successfully completed on (b)(6) two days after the originally scheduled surgery date (b)(6) 2020.It was reported that the postoperative period of the patient and its evolution is unknown.This information does not change the reportabilty of the file.H6: patient code for tissue damage has been added.

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 the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device was returned for evaluation.Quality engineering evaluated the attachment device and the reported condition that the device did not show signs of movement was confirmed.An assessment was performed and it was identified that attachment did not show any signs of movement.After disassembling the attachment, it was identified that the wear parts of the device were dirty and full of residue and rust.It was noted that there were no signs of damage or malfunction with the handpiece device.It was further determined that the device failed pretest for general condition and check the free movement.It was noted that the defects related to the seals and air motors are clearly due to normal wear.The assignable root cause of this condition was determined to be traced to component failure due to normal wear.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: SAGITTAL SAW ATTACHMENT, LONG, 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: 9826357
• MDR Text Key: 189586216
• Report Number: 8030965-2020-01778
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819377929
• UDI-Public: 7611819377929
• 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,Followup
• Report Date: 02/27/2020

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: 05.001.224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/12/2020
• Supplement Dates Manufacturer Received: 03/13/2020; 03/10/2020; 03/31/2020
• Supplement Dates FDA Received: 03/17/2020; 03/26/2020; 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention