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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HP POWER PIN DRIVER KNEE INSTRUMENT : INSERTION DEVICES

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DEPUY ORTHOPAEDICS INC US HP POWER PIN DRIVER KNEE INSTRUMENT : INSERTION DEVICES Back to Search Results
Model Number 9505-02-071
Device Problems Connection Problem (2900); Device-Device Incompatibility (2919)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 10/02/2019
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
It was reported that it was not able to attach the pin driver (p/n: (b)(4)) to a s-rom adapter during the tka surgery on (b)(6) 2019. The surgeon attempted to connect the pin driver to the s-rom adapter however it could not insert and not fixed. It became possible to use it by attaching the pin driver to the trinkle adapter, and the surgery was completed without a surgical delay. There was no adverse consequence to the patient. Although it was confirmed after the surgery, the pin driver and the s-rom adapter did not engaged at all and it could not attach it. No further information is available.
 
Manufacturer Narrative
Product complaint # b)(4). Investigation summary
==
> examination of the returned device was unable to replicate the reported event. No evidence of product malfunction or product error was found and the investigation did not indicate that a broader investigation or corrective action was necessary. 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, a follow-up medwatch will be filed as appropriate.
 
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Brand NameHP POWER PIN DRIVER
Type of DeviceKNEE INSTRUMENT : INSERTION DEVICES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key9226890
MDR Text Key183689098
Report Number1818910-2019-111574
Device Sequence Number1
Product Code HWE
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
Report Date 10/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9505-02-071
Device Catalogue Number950502071
Device Lot NumberJ1008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/15/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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