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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0 TI LCKNG SCR T25 SD 46 F/IM NAILS-S ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0 TI LCKNG SCR T25 SD 46 F/IM NAILS-S ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.005.436S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Physical Asymmetry (4573)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Additional product code: hwc. Complainant part is not expected to be returned for manufacturer review/ investigation. Reporter is a j&j representative. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. Based on the information available, it has been determined that no corrective and preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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) 2021, the patient underwent revision surgery due to implants used causing the patient to lose reduction of the bone. It was unknown if the revision surgery completed successfully. It is unknown if there was a surgical delay. The patient status is unknown. This complaint involves five (5) devices. This report is for (1) 4. 0 ti lckng scr t25 sd 46 f/im nails-s. This is report 5 of 5 for complaint (b)(4).
 
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Brand Name4.0 TI LCKNG SCR T25 SD 46 F/IM NAILS-S
Type of DeviceROD,FIXATION,INTRAMEDULLARY
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 Key12869411
MDR Text Key281212091
Report Number2939274-2021-06809
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103002
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
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number04.005.436S
Device Catalogue Number04.005.436S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/28/2021
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: 11/24/2021 Patient Sequence Number: 1
Treatment
4.0 TI LCKNG SCR T25 SD 28 F/IM NAILS-S; 4.0 TI LCKNG SCR T25 SD 30 F/IM NAILS-S; 9 TI CANNULATED HUMERAL NAIL-EX/300-SILE; TI SPIRAL BLD 42-S FOR TI HUMERAL NAILS
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