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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 85MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 85MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.038.385S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Pain (1994)
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2022, the patient underwent removal surgery due to pain. There was no broken implant reported. The surgeon then converted patient to a total hip arthroplasty. Removed hardware successfully. Patient consequence unknown. This report is for one (1) tfna fenestrated helical blade 85mm - sterile. This is report 2 of 3 for (b)(4).
 
Manufacturer Narrative
Additional procode: ktt. Complainant part is not expected to be returned for manufacturer review/investigation. 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. Part # 04. 038. 385s, synthes lot # h786647, supplier lot # n/a, release to warehouse date: 11 dec 2018, expiration date: 31 oct 2028, manufacturing location: (b)(4). No ncr's were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition. 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.
 
Manufacturer Narrative
Additional procode: ktt. Complainant part is not expected to be returned for manufacturer review/investigation. 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. Part # 04. 038. 385s, synthes lot # h786647, supplier lot # n/a, release to warehouse date: 11 dec 2018, expiration date: 31 oct 2028, manufacturing location: (b)(4). No ncr's were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition. 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 underwent removal surgery due to pain. There was no broken implant reported. The surgeon then converted patient to a total hip arthroplasty. Removed hardware successfully. Patient consequence unknown. This report is for one (1) tfna fenestrated helical blade 85mm - sterile. This is report 2 of 3 for (b)(4).
 
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Brand NameTFNA FENESTRATED HELICAL BLADE 85MM - 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)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13481249
MDR Text Key285256344
Report Number2939274-2022-00390
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number04.038.385S
Device Catalogue Number04.038.385S
Device Lot NumberH786647
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/11/2018
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/08/2022 Patient Sequence Number: 1
Treatment
10/125 DEG TI CANN TFNA 170 - STERILE; 5.0 TI LOCKING SCREW 32- FOR IM NAILS
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