• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HP THREADED PINS HEADED 6 PK; KNEE INSTRUMENT : FIXATION PINS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY ORTHOPAEDICS INC US HP THREADED PINS HEADED 6 PK; KNEE INSTRUMENT : FIXATION PINS Back to Search Results
Model Number 9505-02-089
Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981); Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Patient Problem Not Applicable (3189)
Event Date 11/21/2019
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
The threaded pin got stuck in the cutting block.One they could take out but quite deformed the other one was stuck completely.
 
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
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.Product complaint # : (b)(4).Investigation summary: examination of the returned device confirmed the reported event.The noted damage is consistent with device wear out through heavy high cycle usage in the field and the investigation did not establish a need for corrective action.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HP THREADED PINS HEADED 6 PK
Type of Device
KNEE INSTRUMENT : FIXATION PINS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key9477002
MDR Text Key187944630
Report Number1818910-2019-123309
Device Sequence Number1
Product Code HSB
UDI-Device Identifier10603295227922
UDI-Public10603295227922
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
Report Date 11/25/2019
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 Number9505-02-089
Device Catalogue Number950502089
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2019
Initial Date Manufacturer Received 11/25/2019
Initial Date FDA Received12/16/2019
Supplement Dates Manufacturer Received12/30/2019
01/30/2020
Supplement Dates FDA Received01/07/2020
02/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-