MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC H+PIECE F/PIEZOELECTRIC SYSTEM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 05.001.401

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device manufacture date: the device manufacture date is unavailable; therefore, (b)(4) the manufacturing location is currently not available.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.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the piezoelectric handpiece device was not working when it was in contact with the bones.It was further reported that the device stopped suddenly.According to the reporter, different handpiece devices were tried with the device; however, the issue still persisted.It was not reported if there were any delays in the surgical procedure or if a spare device was available.There was patient involvement reported.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Correction: incorrect serial number: the device serial number was incorrect in the initial report.The serial number has been updated from (b)(4).The udi has been updated accordingly.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The manufacturer location was documented as unknown in the initial report.The location has been updated to (b)(4).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

The actual device was returned for evaluation.During evaluation it was determined that the device passed all manufacturing specifications.Therefore, the reported condition could not be duplicated nor confirmed.An assignable root cause was not determined.It was noted that the device works well (power measured and frequency ok), the pins receiving the led ring were oxidized but working, and the connector became black due to cleaning, however did not affect the operation.A device history review was performed which indicated that there were no relevant issues identified during the manufacture of the device that may have contributed to the reported condition.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.Correction: manufacturer location: the manufacturer location was inadvertently documented as waldenburg in the previous 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.The udi has been updated accordingly.Device manufacture date: the device manufacture date has been updated as 9/10/2016.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

• Brand Name: H+PIECE F/PIEZOELECTRIC SYSTEM
• 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: 7369453
• MDR Text Key: 103426118
• Report Number: 8030965-2018-52401
• Device Sequence Number: 1
• Product Code: HWE
• 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,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.401
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 03/26/2018
• Supplement Dates Manufacturer Received: 07/02/2018; 08/13/2018; 09/17/2018; 09/20/2018; 02/20/2019
• Supplement Dates FDA Received: 07/11/2018; 08/16/2018; 09/18/2018; 09/21/2018; 12/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1