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

Catalog Number 05.001.083

Device Problem Break (1069)

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

Event Date 05/06/2022

Event Type  malfunction  

Manufacturer Narrative

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.Device manufacture date: the device manufacture date is currently unavailable.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 a hand surgery, it was discovered that the double air hose device hose burst during the first use.There was a fifteen- twenty minute delay to the surgical procedure.A spare device was used to complete the surgery without any issues.There was patient involvement reported.There were no reports of 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.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: h4: device manufacture date: the device manufacture date was unknown in the initial report.The device manufacture date has been updated as 3/10/2022.

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: h6: device history review: a device history review was performed which indicated that there were no relevant issues identified during the manufacture of the device that may have contributed to the reported condition.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the device failed visual inspection due to a tear in the hose.It was determined that the outer hose was separated into three pieces and the defect area was about 2m from the coupling.It was further determined that based on the visual assessment of the teared area the rupture was caused by an outer action on the hose and it was most likely that the outer hose was pinched up to a degree so the material suffered damage.It was further determined that the device failed pretest for general condition and check outer hose.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to user, which is user error.

• 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: 14391454
• MDR Text Key: 292485872
• Report Number: 8030965-2022-03178
• Device Sequence Number: 1
• Product Code: HBB
• UDI-Device Identifier: 07611819831520
• UDI-Public: 07611819831520
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K093361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/13/2022

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: 05.001.083
• Device Lot Number: 34625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/13/2022
• Supplement Dates Manufacturer Received: 06/02/2022; 06/09/2022; 07/28/2022
• Supplement Dates FDA Received: 06/07/2022; 06/20/2022; 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• 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