• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 420MM/RIGHT-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 420MM/RIGHT-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.037.262S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Arthritis (1723)
Event Type  Injury  
Manufacturer Narrative
Patient identifier: (b)(6). Manufacturing location: (b)(4), manufacturing date: september 20, 2018, expiration date: august 31, 2028, part number: 04. 037. 262s, 12mm/130 deg ti cann tfna 420mm/right- sterile, lot number: h735696 (sterile), lot quantity: (b)(4). One piece was scrapped in cell at op #30, gundrill, after a tool breakage. Work order traveler met all inspection acceptance criteria apart from the one piece noted. Inspection sheet, in-process / inspect dimensional / final met all inspection acceptance criteria apart from the one piece noted. Inspection sheet, tfna assembly inspection met all inspection acceptance criteria. Packaging label log (pll) lppf , lmd was reviewed and determined to be conforming. Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified. Scn 15498 supplied by ethicon (abq) was reviewed and determined to be conforming. This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿removal due to terrible arthritis¿ does not indicate breakage of the nail or any of its components. Therefore, review of the raw materials would not be pertinent to the reported complaint condition. This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. Product was not returned. 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) 2020, the patient underwent a hardware removal of nail, helical blade, and locking screws followed by a total hip replacement surgery due to terrible arthritis. Initially, the patient was implanted with a trochanteric femoral nail advanced (tfna) on an unknown date. The hardware removal and total hip replacement surgery was successfully completed. There was no patient consequence. Concomitant devices reported: tfna fenestrated helical blade 100mm (part number 04. 038. 400, lot h556431, quantity 1); 5. 0mm ti locking screw w/t25 stardrive 48mm for im nails (part number 04. 005. 538, lot unknown, quantity 1); 5. 0mm ti locking screw w/t25 stardrive 48mm for im nails (part number 04. 005. 538, lot unknown, quantity 1). This report involves one (1) 12mm/130 deg ti cann tfna 420mm/right-sterile. This is report 1 of 4 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name12MM/130 DEG TI CANN TFNA 420MM/RIGHT-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)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11139918
MDR Text Key225770932
Report Number2939274-2021-00124
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number04.037.262S
Device Catalogue Number04.037.262S
Device Lot NumberH735696
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 Received12/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/20/2018
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: 01/08/2021 Patient Sequence Number: 1
Treatment
5.0MM TI LOCKING SCREW; 5.0MM TI LOCKING SCREW; TFNA FENESTRATED HELICAL BLADE
-
-