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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HP EM TIBIAL JIG SPIKED UPROD; KNEE INSTRUMENT : ALIGNMENT DEVICES
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DEPUY INTERNATIONAL LTD - 8010379 HP EM TIBIAL JIG SPIKED UPROD; KNEE INSTRUMENT : ALIGNMENT DEVICES Back to Search Results
Model Number 9505-01-230
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
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.
 
Event Description
It was reported as "tibial spike broke off tibial resection guide.".
 
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).Investigation summary: examination of the returned device can confirm the reported event.The device is broken.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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
Manufacturer Narrative
Product complaint (b)(4).Investigation summary: examination of the returned device can confirm the reported event.The device is broken.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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
HP EM TIBIAL JIG SPIKED UPROD
Type of Device
KNEE INSTRUMENT : ALIGNMENT DEVICES
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12883354
MDR Text Key281333983
Report Number1818910-2021-26395
Device Sequence Number1
Product Code HTZ
UDI-Device Identifier10603295225355
UDI-Public10603295225355
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 11/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9505-01-230
Device Catalogue Number950501230
Device Lot NumberSO2036729
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/27/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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