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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ANGLED RMR DRIVER HUDSON; HIP INSTRUMENTS : ADAPTORS

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DEPUY INTERNATIONAL LTD - 8010379 ANGLED RMR DRIVER HUDSON; HIP INSTRUMENTS : ADAPTORS Back to Search Results
Model Number 9200-10-031
Device Problems Device Damaged Prior to Use (2284); Device-Device Incompatibility (2919); Appropriate Term/Code Not Available (3191)
Patient Problems Not Applicable (3189); No Code Available (3191)
Event Date 06/09/2020
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
Instrument was delivered broken.It could not be used.This impacted the flow of the surgery and time was lost.Potential adverse event as the right material was not placed.Note: 3rd party which is delivering the orthokits had also been informed about this complaint (etq-complaint reference com-352717).
 
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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: h6 (patient and device codes) h6 patient code: no code available (3191) used to capture the surgery prolonged and insufficient information.H6 device code: no code available (3191) used to capture the customer feedback: dissatisfaction if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint #
=
> pc(b)(4) investigation summary
=
> review of the photo could not confirm the failure mode.Root cause undetermined.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.H10 additional narrative: added: e1 (facility name).
 
Manufacturer Narrative
Product complaint # (b)(4).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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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.
 
Manufacturer Narrative
Product complaint # (b)(4).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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: d10 corrected: h3 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint (b)(4).Investigation summary: review of the photo could not confirm the failure mode.Root cause undetermined.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.
 
Manufacturer Narrative
Product complaint # (b)(4).Re-opened as device was received in 28 aug 2020.Investigation summary examination of the returned instrument cannot confirm the complaint.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.
 
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Brand Name
ANGLED RMR DRIVER HUDSON
Type of Device
HIP INSTRUMENTS : ADAPTORS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
MDR Report Key10198245
MDR Text Key196578968
Report Number1818910-2020-14470
Device Sequence Number1
Product Code HWE
UDI-Device Identifier10603295221906
UDI-Public10603295221906
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/09/2020
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 Number9200-10-031
Device Catalogue Number920010031
Device Lot NumberMJ3643001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2020
Initial Date Manufacturer Received 06/09/2020
Initial Date FDA Received06/25/2020
Supplement Dates Manufacturer Received06/09/2020
07/06/2020
08/10/2020
09/01/2020
08/28/2020
11/13/2020
Supplement Dates FDA Received07/03/2020
07/07/2020
08/14/2020
09/01/2020
09/17/2020
11/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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