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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC AIR PEN DRIVE; MOTOR, DRILL, PNEUMATIC
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DEPUY SYNTHES PRODUCTS LLC AIR PEN DRIVE; MOTOR, DRILL, PNEUMATIC Back to Search Results
Catalog Number 05.001.080
Device Problem Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/22/2019
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4).The actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.
 
Event Description
It was reported from (b)(6) that the air pen drive device engine was making very loud noise.It was unknown if the event occurred during surgery.There were no delays to a surgical procedure.It was unknown if there was patient involvement.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 will be submitted accordingly.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Upon further investigation, it was determined that mfr# (b)(4) is a duplicate of mfr# (b)(4).Reference mfr # (b)(4) for all further reporting regarding this event.If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Corrected data: d10: the date returned for evaluation was reported as (b)(6) 2019, the correct date is (b)(6) 2019.H10: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device did not function and was locked.The device also failed pretest for check external leak tightness and check internal leak tightness.Therefore, the reported condition was confirmed.It was noted that the device was locked due to some of the parts being damaged by failures in the cleaning and lubrication processes, there was excess liquid residue detected inside the device, and there were signs of oxidation.The assignable root cause was determined to improper device maintenance.If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
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Brand Name
AIR PEN DRIVE
Type of Device
MOTOR, DRILL, PNEUMATIC
Manufacturer (Section D)
DEPUY SYNTHES PRODUCTS LLC
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8469950
MDR Text Key140503428
Report Number8030965-2019-62383
Device Sequence Number1
Product Code HBB
UDI-Device Identifier07611819830899
UDI-Public7611819830899
Combination Product (y/n)N
PMA/PMN Number
K093361
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 03/22/2019
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 Number05.001.080
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2019
Initial Date Manufacturer Received 03/22/2019
Initial Date FDA Received04/01/2019
Supplement Dates Manufacturer Received04/08/2019
05/30/2019
Supplement Dates FDA Received04/11/2019
06/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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