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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: TFNA ROD, FIXATION, INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: TFNA ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Non-union Bone Fracture (2369); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown tfna construct/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). Without a lot number the device history records review could not be completed. Product was not returned. 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. 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
This report is being filed after the review of the following journal article: goodnough h. , et al (2020) trochanteric fixation nail advanced with helical blade and cement augmentation: early experience with a retrospective cohort, european journal of orthopaedic surgery & traumatology vol. , pages 4-6 (usa). This retrospective cohort study aims to report on the early clinical and radiographic outcomes of cement augmentation of cmns in the treatment of geriatric it proximal femur fractures. From 2018 to 2019, all it femur fractures (ao/ota 31a1-3) treated with intertrochanteric (it) femur fractures with a cephalomedullary nail (cmns) were identified. Seventy-five patients underwent cephalomedullary nailing for it fractures. Twenty-two were additionally treated with augmentation (22/75). Fifty-three patients with cephalomedullary nails for it fractures had 3-month follow-up, including 11/53 treated with pmma augmentation. 11 patients (10 females, 1 male) age at surgery 86. 91 (75¿95) with it femur fractures were treated with pmma cement-augmented cmns were included, along with 33 propensity matched controls (28 females,5 males) treated with tfna without augmentation. In each case the trochanteric fixation nail advanced (tfna) (synthes, paoli, pa) with polymethylmethacrylate (pmma) (traumacem v+ cement, synthes, paoli, pa) was used. A minimum of 3-month follow-up was done. The following complications were reported as follows: a case of a (b)(6) year old female in the augmentation group where her fracture was not healed. (the same patient: radiographic healing was confirmed in 10 patients of patients with augmentation at 3 months postoperatively. The remaining patient had evidence of callus formation but was lost to follow-up after 3 months. ) one of the 3 repeat operations in the conventional fixation group for post-traumatic arthritis. One of the 3 repeat operations in the conventional fixation group, for deep postoperative hematoma. 2 non-union for tfna group. There was no difference in collapse (sliding) at the fracture site at 6 weeks between groups. Tfna-pmma: 4. 72 (2. 35¿9. 26) mm ; tfna 5. 67 (2. 21¿7. 58) mm. One of the 3 repeat operations in the conventional fixation group, one for cut-out. There were 2 radiographic cut-out for tfna group. This report is for an unknown synthes trochanteric fixation nail advanced (tfna). It captures the reported events of reoperation due to post-traumatic arthritis and deep postoperative hematoma, nonunion and collapse (sliding) at the fracture site at 6 weeks. This is report 3 of 5 for (b)(4).
 
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Brand NameUNK - CONSTRUCTS: TFNA
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10551334
MDR Text Key207527774
Report Number2939274-2020-04196
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2020
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: 09/17/2020 Patient Sequence Number: 1
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