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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC AIR REAMER/DRILL II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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DEPUY SYNTHES PRODUCTS LLC AIR REAMER/DRILL II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 511.606
Device Problem Output below Specifications (3004)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.However, since the investigation is still on-going, the assignable root cause could not be determined at this time.Once investigation has been completed, a supplemental medwatch will be submitted accordingly.
 
Event Description
It was reported by(b)(6) that during service and evaluation, it was determined that the air reamer/drill device had low power.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2019.All available information has been disclosed.If additional information should 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.Correction: device availability: d10: the device availability date was incorrect in the initial report.The date has been updated from 12/16/2019 to 11/29/2019.Device evaluation: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device failed pretest for check power with test stand, minimum 190 w to 260 w (watt).Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to component failure, which is normal wear (faulty parts).If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
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Brand Name
AIR REAMER/DRILL II
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
DEPUY SYNTHES PRODUCTS LLC
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9528667
MDR Text Key190520379
Report Number8030965-2019-71268
Device Sequence Number1
Product Code HWE
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
Report Date 12/16/2019
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 Number511.606
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2019
Initial Date Manufacturer Received 12/16/2019
Initial Date FDA Received12/29/2019
Supplement Dates Manufacturer Received01/24/2020
Supplement Dates FDA Received01/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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