MAUDE Adverse Event Report: SYNTHES GMBH DOUBLE AIR HOSE, 3M, FOR AIR PEN DRIVE; MOTOR, DRILL, PNEUMATIC

Catalog Number 05.001.083

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 01/01/2024

Event Type  malfunction  

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.H10 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.H4: the date of manufacture is unknown.Udi: (b)(4).

Event Description

It was reported from colombia that during an unspecified surgical procedure, it was observed that the double air hose device exploded leaving the coupling stuck in the handpiece device.It was further observed that the device motor was unusable and there was nitrogen leaking from the hose, there was a ten minute delay in the surgical procedure.The facility was loaned a device to continue the procedure.The procedure was completed successfully.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.The date of event was unknown but was known to have occurred in 2024.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: DOUBLE AIR HOSE, 3M, FOR AIR PEN DRIVE
• Type of Device: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 19043331
• MDR Text Key: 340123200
• Report Number: 8030965-2024-04550
• Device Sequence Number: 1
• Product Code: HBB
• UDI-Device Identifier: 07611819831520
• UDI-Public: 07611819831520
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K093361
• 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
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.083
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1