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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC DOUBLEAIRHOSE L5M F/SYST SYNTHES; INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT
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DEPUY SYNTHES PRODUCTS LLC DOUBLEAIRHOSE L5M F/SYST SYNTHES; INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 519.530
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
Device manufacture date: the device manufacture date was unavailable.The manufacturing location was unknown.Reporter's phone number was not provided.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 the hose on the engine device exploded in ¿cx¿.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported, however, it was reported that the event occurred in 2020.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.During repair, an evaluation was performed and it was determined that the air hose device ruptured, there was component damage, and there was an air leak.It was further determined that the device failed pretest for external pressure test, internal pressure test, check outer hose, check specific wall coupling, check handpiece coupling, check for correctness of specific single air hose, and general condition.Therefore, the reported condition that the air hose device exploded was confirmed.The assignable root cause was determined to be traced to user, which is user error.
 
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.B5 additional information: upon subsequent follow-up with the reporter, additional information was received.The reporter stated that "cx" is the abbreviation for surgery.
 
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Brand Name
DOUBLEAIRHOSE L5M F/SYST SYNTHES
Type of Device
INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
DEPUY SYNTHES PRODUCTS LLC
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10421334
MDR Text Key204408178
Report Number8030965-2020-05726
Device Sequence Number1
Product Code HSZ
UDI-Device Identifier07611819037182
UDI-Public7611819037182
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 07/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number519.530
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2020
Date Manufacturer Received10/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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