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

Catalog Number 519.530

Device Problem Break (1069)

Patient Problems Hearing Impairment (1881); Tinnitus (2103)

Event Date 12/14/2022

Event Type  Injury  

Event Description

This is event 2 of 2 of the same event.It was reported from brazil that during an unspecified surgical procedure, it was observed that the pneumatic hose device burst while in use with the compact air drive device.According to the reporter, the surgeon stated that he could not hear from his left ear and had tinnitus.The surgeon went to the emergency room and was informed that he had a decrease in the left auditory capacity and was recommended to a specialist in otorhinolaryngology o.R.L and positive roomberg testing.There were no delays in the surgical procedure.It was unknown if a spare device was available for use.There was patient involvement.There were no report of injuries to the patient, medical intervention or prolonged hospitalization of the patient.All available information has been disclosed.If additional information should become available, a supplemental medwatch 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.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.Additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Concomitant medical products: compact air drive device, therapy date: on (b)(6) 2022.Udi: (b)(4).

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.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.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, a supplemental medwatch report will be submitted accordingly.Udi: (b)(4).

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.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.Additional narrative: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device outer hose was ruptured and not all the pieces from the outer hose were received.Furthermore, the wall coupling (male side) showed slight damage.Due to the ruptured outer hose other test steps failed.The rubber from the hose was inspected at the bursting point, no blockage of the air ways could be detected.Neither was an unconformity of the rubber material detected.Potentially the hose was weakened on the bursting point since it¿s on the side of the handpiece coupling and gets moved and bend around more tension is applied at this point.Second possibility could also be that the air pressure was too high.Since parts of the hose are missing a clear root cause cannot be determined at this stage.The device also failed pretests for general condition, internal pressure test and external pressure test.Therefore, the reported condition was confirmed.The assignable root cause for the cosmetic damage was traced to user error and the root cause for the ruptured hose could not be established.A device history review was performed, and no non-conformances were detected related to the reported condition.It was reported that the device was returned for evaluation on jun 02, 2023, the correct date is jan 31, 2023.

• 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
• Manufacturer (Section G): SYNTHES PRODUKTIONS GMBH; hauptstrasse 24; waldenburg 4437 ; SZ 4437
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 16026742
• MDR Text Key: 305931647
• Report Number: 8030965-2022-11417
• Device Sequence Number: 1
• Product Code: HSZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention