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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 90MM STERILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 90MM STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.038.290S
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Non-union Bone Fracture (2369); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Patient age, dob & weight not provided for reporting. Event date: unknown - 2018. Implant date: the original surgery was approximately two years ago on an unknown date and was done out of state. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities. If additional is obtained that was not available for the initial med-watch, the investigation will be updated as applicable, and a follow-up med-watch will be filed as appropriate. 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 the patient underwent hardware removal of a right tfn-advanced proximal femoral nailing system (tfna) on (b)(6) 2018 due to femoral head cutout and non-union. The surgeon was converting to a total hip. The initial surgery was approximately two years ago and was done out of state. During the procedure the surgeon removed one (1) 11mm/130 deg ti cann tfna 170mm, one (1) tfna helical blade 90mm, and an unknown 5. 0mm screw. The implants were removed without incident. There is no additional information. Concomitant device(s) reported: cannulated nail (part #: 04. 037. 142s, lot #: h069675, qty: 1). Locking screw (part #: unknown, lot #: unknown, qty: 1). This report is 1 of 1 for (b)(4).
 
Manufacturer Narrative
Device used for treatment, not diagnosis. Reported: device history lot part number: 04. 038. 290s, lot number: h069675, part manufacture date: n/a, manufacturing location: n/a, part expiration date: n/a, nonconformance noted: n/a. Dhr record review: a review of the device history record could not be performed as the product was not returned and the lot number provided is not valid for elmira. Device history review: a review of the device history record could not be performed as the product was not returned and the lot number provided is not valid for elmira. Investigation summary: product complaint 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. Remove expiration date from previous mw. Synthes manufacturing location reported for the subject device. Complainant part is not expected to be returned for manufacturer review/investigation. If additional information is made available, the investigation will be updated as applicable.
 
Event Description
Update: 4/4/2018: concomitant device lot # is: h071282.
 
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Brand NameTFNA HELICAL BLADE 90MM STERILE
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)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7412729
MDR Text Key104894222
Report Number2939274-2018-51558
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2018
Device Model Number04.038.290S
Device Catalogue Number04.038.290S
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 Received04/04/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/10/2018 Patient Sequence Number: 1
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