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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 4.5 VA-LCP CRVD COND PL/12HOLE/266/LT-S PLATE, FIXATION, BONE

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JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 4.5 VA-LCP CRVD COND PL/12HOLE/266/LT-S PLATE, FIXATION, BONE Back to Search Results
Model Number 02.124.413S
Device Problem Break (1069)
Patient Problems Non-union Bone Fracture (2369); Swelling/ Edema (4577)
Event Date 08/04/2018
Event Type  Injury  
Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is an attorney. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or 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. Photo investigation: the device was not returned. A photo-investigation was performed on all the images located under pc attachment received at 14-may-2021. Upon inspecting all the photos provided, the 4. 5 va-lcp crvd cond pl/12hole/266/lt-s was found to be fractured/cracked on side of one of the variable angle combination hole near to proximal side of plate. The root cause of the complaint condition cannot be confirmed based on the available images. 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. Conclusion: the complaint condition can be confirmed during photo investigation. During the investigation, no product design issues or discrepancies were observed. No manufacturing issues were noted during investigation. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Therefore, it has been determined that no corrective and/or preventive action is proposed. Device history lot - a manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided. 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) 2018, patient underwent an open reduction internal fixation of left supracondylar femur with intra -articular extension for a left supracondylar femur fracture nonunion with hardware failure due to swelling, plate breakage and nonunion. Concomitant device reported: 4. 5mm cortex screw self-tapping 36mm (part # 214. 836 lot # unknown, quantity# 1), 5. 0mm variable angle lockng screw/slf-tpng/strdrv/36mm (part # 02. 231. 236 , lot # unknown, quantity# 1), 5. 0mm variable angle lockng screw/slf-tpng/strdrv/34mm (part # 02. 231. 234 lot # unknown, quantity# 2), 5. 0mm variable angle lockng screw/slf-tpng/strdrv/36mm (part # 02. 231. 236 , lot # unknown, quantity# 6), 4. 5mm cortex screw self-tapping 80mm (part # 214. 880 , lot # unknown, quantity# 6). This report is for one (1) 4. 5mm va-lcp curved condylar plate/12hole/266mm/lt-ster. This is report 1 of 1 for complaint (b)(4).

 
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Brand Name4.5 VA-LCP CRVD COND PL/12HOLE/266/LT-S
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.
no. 299, changyang street
suzhou industrial park
suzhou, jiangsu 21512 6
CH 215126
Manufacturer (Section G)
DEPUY MOTION SARL
chemin blanc 38
le locle
SZ
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11952433
MDR Text Key267240878
Report Number3006356043-2021-00001
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK083025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 05/12/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/07/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number02.124.413S
Device Catalogue Number02.124.413S
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 06/07/2021 Patient Sequence Number: 1
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