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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RFNA / 12 / 320 5 DEG BEND / STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC RFNA / 12 / 320 5 DEG BEND / STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.233.232S
Device Problems Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2022
Event Type  Injury  
Manufacturer Narrative
Additional product code: hwc. Complainant part is not expected to be returned for manufacturer review/investigation. A photo investigation was completed: visual analysis of the provided photo revealed that there was no damage or defects with the rfna nail. As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed. As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications. The overall complaint was not confirmed. There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities. Device was used for treatment, not diagnosis. 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 on (b)(6) 2022, the patient under a hardware removal procedure to remove the lateral oblique locking screw of the retrograde femoral nail advanced (rfna) because it had backed out. This report is for a rfna nail. This is report 1 of 2 for (b)(4).
 
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Brand NameRFNA / 12 / 320 5 DEG BEND / STERILE
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13824280
MDR Text Key287520695
Report Number2939274-2022-00951
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201346
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.233.232S
Device Catalogue Number04.233.232S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/19/2022 Patient Sequence Number: 1
Treatment
LOCKING SCREW FOR IM NAIL 5/ 86/ XL25; UNK - END CAPS; UNK - NUTS; UNK - SCREWS: LOCKING; UNK - WASHERS
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