MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC DOUBLEAIRHOSE L5M F/SYST SYNTHES; INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT

Catalog Number 519.530

Device Problem Break (1069)

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

Event Date 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

Udi: serial number unknown; (b)(4).The serial number was unknown; therefore, the device manufacture date is unknown.The manufacturing location is unknown.Concomitant med products and therapy dates: tendonharv pigtail peeler device, restore fullflute ream devices, speedtrap grn/white device, drill bit devices, drill device, (b)(6) 2019.The reporter¿s phone number was not provided.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the double air hose device which was used to connect the nitrogen and the engine to run, exploded at a critical time in the middle of the procedure.The reporter further stated that there were several inconveniences that occurred during the surgery.According to the reporter, the device used to remove the insert ¿pigtail tendon peeler¿ was the device that arrived for the patient.According to the reporter, the device tore the insert, and that was one of the reasons why the second ¿lca¿ was canceled, since it was necessary to remove the other tenotome (gun type) that came on the other device.It was further reported that the tibial drill bit device number eight of the two devices were without edges.The other drill device was also removed from the second device to try to make the tibial tunnel without passing too much difficulty, but they were in the same conditions.The reporter further indicated that one of the implants arrived packed, but without any contents inside the box.It was reported that there was no implant inside.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

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.Manufacturing site name: the manufacturer location was incorrectly documented as oberdorf in the previous report.The manufacturing location is currently unknown.Device evaluation: the actual device was returned for evaluation.During repair, it was determined that the hose was ruptured.It was further observed that the outer hose burst during use.It was further determined that the device failed pretest for external pressure test; note setting of power air supply 8 bar ± 2 bar, check outer hose and general condition.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to component failure.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.Udi: (b)(4).Serial number: the serial number was unknown in the initial report.The serial number has been updated as (b)(4).The manufacturer location was unknown 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.Device manufacture date: the device manufacture date was unknown in the initial report.The device manufacture date has been updated as 12/20/2012.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.Upon subsequent follow-up with the customer, additional information was obtained.The reporter clarified that the procedure was cancelled, and it was the second ¿lca¿ scheduled for that day at the same institution.It was reported that the device was delivered to a second patient.According to the reporter, the user ¿took off the hose for replacing the hose that had broken and the number 8 drill bits¿.It was reported that the patient was not admitted and therefore, did not receive the anesthesia.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 history record review: a device history review was performed and no non-conformances were detected related to the reported condition.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: DOUBLEAIRHOSE L5M F/SYST SYNTHES
• Type of Device: INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9309837
• MDR Text Key: 194606508
• Report Number: 8030965-2019-70209
• Device Sequence Number: 1
• Product Code: HSZ
• 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: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 519.530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1