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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 GLOBAL UNITE TR BODY SZ10 135; EXTREMITY INSTRUMENTS : PROXIMAL BODY TRIALS

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DEPUY ORTHOPAEDICS, INC. 1818910 GLOBAL UNITE TR BODY SZ10 135; EXTREMITY INSTRUMENTS : PROXIMAL BODY TRIALS Back to Search Results
Catalog Number 210030015
Device Problems Break (1069); Peeled/Delaminated (1454)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/08/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that they had some paint coming off two separate trials.Hospitals would not let them use in cases and need to be replaced.No surgical delay.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Additional narrative: product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported event.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.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.
 
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Brand Name
GLOBAL UNITE TR BODY SZ10 135
Type of Device
EXTREMITY INSTRUMENTS : PROXIMAL BODY TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key8641322
MDR Text Key146479669
Report Number1818910-2019-94558
Device Sequence Number1
Product Code KWS
UDI-Device Identifier10603295416074
UDI-Public10603295416074
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
Report Date 05/08/2019
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 Number210030015
Device Lot NumberNW148543
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2019
Initial Date Manufacturer Received 05/08/2019
Initial Date FDA Received05/24/2019
Supplement Dates Manufacturer Received05/08/2019
06/24/2019
Supplement Dates FDA Received06/07/2019
06/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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