MAUDE Adverse Event Report: SYNTHES GMBH DOUBLE AIR HOSE, 5M, FOR AIR PEN DRIVE; MOTOR, DRILL, PNEUMATIC

Catalog Number 05.001.084

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

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

Event Date 11/04/2023

Event Type  malfunction  

Event Description

This is report 2 of 2 of the same event: it was reported from colombia that at the beginning of an unspecified surgical procedure, it was observed that the air hose device was triggered.The reporter further clarified that the hose exploded.According to the reporter, the device was replaced with a second air hose, which also experienced the same issue.A third device was used to complete the surgery successfully.It was reported that there was a five-minute delay to the surgical procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.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.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: d10: concomitant med products and therapy dates: air hose device, (b)(6) 2023.H4, g1-1: the device manufacture date and the manufacturing site name are 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.Udi: (b)(4).Reference manufacturer report number 8030965-2023-14567 for the first air hose device as it was used in the same event.

• Brand Name: DOUBLE AIR HOSE, 5M, 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: 18180843
• MDR Text Key: 328618362
• Report Number: 8030965-2023-14569
• Device Sequence Number: 1
• Product Code: HBB
• UDI-Device Identifier: 10886982129055
• UDI-Public: 10886982129055
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.084
• Device Lot Number: 5400005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1