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

Catalog Number 519.530

Device Problems Break (1069); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Concomitant med products and therapy dates: compact air drive device and quick coupling device (b)(6) 2021.As of this date, the device has not been returned for evaluation.Therefore, the reported condition cannot be confirmed and/or duplicated.Udi  (b)(4).

Event Description

It was reported from (b)(6) that during an open reduction internal fixation (orif) surgical procedure for a femoral trochanteric fracture using a proximal femoral nailing system (tfna), it was observed that the double air hose system started making a loud noise and burst.The air hose device was being used with a compact air drive device and a quick coupling device.It was reported that there was a less than 30-minute delay in the procedure, and the procedure was successfully completed.It was not reported if there was a spare device available for use.There was patient involvement reported.There were no reports of 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

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The actual device was returned for evaluation.Quality engineering evaluated the double air hose device, and it was determined that the device failed pre-test for visual inspection, general condition, check outer hose, and external pressure test.The hose was received with outer hose burst 360° all along its circumference and some blue tape was detected wrapped around the "shoes".It was noted that the inner hose passed testing on leakage without failure.However, the outer hose was ruptured right next to the handpiece coupling.It was determined that due to the age and location of the burst, it is likely the material suffered damage during use and when the exhaust air tube was blocked the hose burst at its weakest part.It was further determined that the burst must have been caused by inadvertently blocking the outer hose as the rest of the outer tube and the handpiece coupling were transmitting air without resistance.It was noted that the purpose for the detected blue tape could not be identified and it did not block the exhaust air sufficiently to block the outer hose.It was determined that the event of the hose rupture could be linked to user error.The device should have been annually assessed by an authorized service center to assess regular wear over time, therefore a second root cause of improper maintenance was determined to have contributed to the event.A review of the service history record indicates that the device has not been serviced for a service condition that is relevant to the current reported condition.

• Brand Name: DOUBLEAIRHOSE L5M F/SYST SYNTHES
• Type of Device: INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11448720
• MDR Text Key: 244263663
• Report Number: 8030965-2021-01525
• Device Sequence Number: 1
• Product Code: HSZ
• UDI-Device Identifier: 07611819037182
• UDI-Public: 7611819037182
• 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
• Report Date: 02/25/2021

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: 519.530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/09/2021
• Supplement Dates Manufacturer Received: 03/26/2021
• Supplement Dates FDA Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1