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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP*2 INTRAMED TIB ALIGNMENT DE; KNEE INSTRUMENT : ALIGNMENT DEVICES

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DEPUY ORTHOPAEDICS INC US SP*2 INTRAMED TIB ALIGNMENT DE; KNEE INSTRUMENT : ALIGNMENT DEVICES Back to Search Results
Model Number 96-6315
Device Problems Component Missing (2306); Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/28/2018
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
 
Event Description
It was reported that the screw fell out of the im tibial guide.No surgical delay.
 
Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned device confirmed the screw component has become disassembled.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.
 
Manufacturer Narrative
Product complaint (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned device confirmed the screw component has become disassembled.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
 
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Type of Device
KNEE INSTRUMENT : ALIGNMENT DEVICES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8209038
MDR Text Key131828770
Report Number1818910-2019-79572
Device Sequence Number1
Product Code HWT
UDI-Device Identifier10603295247791
UDI-Public10603295247791
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 01/23/2019
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 Model Number96-6315
Device Catalogue Number966315
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2019
Initial Date Manufacturer Received 12/28/2018
Initial Date FDA Received01/02/2019
Supplement Dates Manufacturer Received01/23/2019
04/24/2019
09/17/2020
Supplement Dates FDA Received01/25/2019
04/25/2019
09/17/2020
Patient Sequence Number1
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