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

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).

• Brand Name: 12MM/130 DEG TI CANN TFNA 420MM/RIGHT-STERILE
• Type of Device: ROD, 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 Key: 11139918
• MDR Text Key: 225770932
• Report Number: 2939274-2021-00124
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982097422
• UDI-Public: (01)10886982097422
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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 Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.037.262S
• Device Catalogue Number: 04.037.262S
• Device Lot Number: H735696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.0MM TI LOCKING SCREW; 5.0MM TI LOCKING SCREW; TFNA FENESTRATED HELICAL BLADE
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR